今日の臨床サポート

院内肺炎

概要・推奨   

  1. 院内肺炎(hospital-acquired pneumonia、HAP)においては、耐性菌を考慮に治療を決定することが推奨される(推奨度2)。
  1. HAPのワークアップにおいては血液培養2セットを採取することが推奨される(推奨度2)。
  1. HAPを疑った際には良質の喀痰採取に努め、そのときにはグラム染色と培養検査を行うことが推奨される(推奨度2)。
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薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
上原由紀 : 特に申告事項無し[2021年]
監修:具芳明 : 特に申告事項無し[2021年]

改訂のポイント:
  1. 定期レビューを行い、ガイドラインと文献の入れ替えを行った。

病態・疫学・診察

疾患情報  
  1. 院内肺炎(hospital-acquired pneumonia、HAP)は、入院48時間以降に新たに出現した肺炎を指す。そのうち人工呼吸器が装着されて48時間以後に出現したものを人工呼吸器関連肺炎(ventilator-associated pneumonia、VAP)と呼ぶ。米国などでは入院の閾値が高く、患者はより重症であることが多く、HAPにVAPも多く含まれる。一方日本では療養病床等で発生した肺炎もHAPに含まれ、比較的軽症患者が多いため、HAPに占めるVAPの割合は少ない。院内肺炎の議論をしたりデータを検討したりする場合は、国ごとの医療事情の違いを考慮しなければならない。各国・地域、各医療機関によって原因菌や感受性パターンが異なるため、一律の治療戦略が立てづらいことにも留意する。ここではVAPを除くHAPに限定して議論する。
  1. HAPの診断は困難であり、一意的な診断基準は存在しない。急性発症の発熱、呼吸状態の悪化、咳嗽の増加、喀痰の増加、胸部聴診上のラ音、画像での浸潤影などを総合的に評価して診断する。鑑別疾患は心不全、肺塞栓症、肺胞出血など多岐にわたる。
  1. VAPと異なり、非VAPのHAPでは下気道の検体採取が困難で、グラム染色や培養検査が行いにくい。良質の喀痰が採取された場合はグラム染色の感度は良い(ただし菌がみえないときに除外できるほど感度は高くない)。
  1. 血液培養の陽性率は低いが、陽性時の原因菌同定やデエスカレーションおよび治療期間の決定の一助となるため推奨される。その際は2セット採取する。
  1. 感度・特異度は限定されているが、CRPやプロカルシトニン(PCT)のようなバイオマーカーを補助的に用いてもよい。
  1. 必要に応じて胸部CTや動脈血ガス分析などを用いる。
問診・診察のポイント  
  1. 院内の発熱患者では必ず鑑別に入れ、HAPのワークアップを行う。院内の発熱患者で感染症が原因の場合、尿路感染、カテーテル関連血流感染、創部感染(術後の場合)、肺炎が高い頻度でみられる。

これより先の閲覧には個人契約のトライアルまたはお申込みが必要です。

最新のエビデンスに基づいた二次文献データベース「今日の臨床サポート」。
常時アップデートされており、最新のエビデンスを各分野のエキスパートが豊富な図表や処方・検査例を交えて分かりやすく解説。日常臨床で遭遇するほぼ全ての症状・疾患から薬剤・検査情報まで瞬時に検索可能です。

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文献 

著者: Nieves Sopena, Eva Heras, Irma Casas, Jordi Bechini, Ignasi Guasch, Maria Luisa Pedro-Botet, Silvia Roure, Miquel Sabrià
雑誌名: Am J Infect Control. 2014 Jan;42(1):38-42. doi: 10.1016/j.ajic.2013.06.021. Epub 2013 Nov 5.
Abstract/Text BACKGROUND: Hospital-acquired pneumonia (HAP) is one of the leading nosocomial infections and is associated with high morbidity and mortality. Numerous studies on HAP have been performed in intensive care units (ICUs), whereas very few have focused on patients in general wards. This study examined the incidence of, risk factors for, and outcomes of HAP outside the ICU.
METHODS: An incident case-control study was conducted in a 600-bed hospital between January 2006 and April 2008. Each case of HAP was randomly matched with 2 paired controls. Data on risk factors, patient characteristics, and outcomes were collected.
RESULTS: The study group comprised 119 patients with HAP and 238 controls. The incidence of HAP outside the ICU was 2.45 cases per 1,000 discharges. Multivariate analysis identified malnutrition, chronic renal failure, anemia, depression of consciousness, Charlson comorbidity index ≥3, previous hospitalization, and thoracic surgery as significant risk factors for HAP. Complications occurred in 57.1% patients. The mortality attributed to HAP was 27.7%.
CONCLUSIONS: HAP outside the ICU prevailed in patients with malnutrition, chronic renal failure, anemia, depression of consciousness, comorbidity, recent hospitalization, and thoracic surgery. HAP in general wards carries an elevated morbidity and mortality and is associated with increased length of hospital stay and increased rate of discharge to a skilled nursing facility.

Copyright © 2014 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.
PMID 24199911  Am J Infect Control. 2014 Jan;42(1):38-42. doi: 10.1016・・・
著者: Akira Watanabe, Katsunori Yanagihara, Shigeru Kohno, Toshiharu Matsushima, HAP study group
雑誌名: Intern Med. 2008;47(4):245-54. Epub 2008 Feb 15.
Abstract/Text OBJECTIVE: The aim of this study was to investigate the pathophysiology of hospital-acquired pneumonia (HAP) and the clinical efficacy of its first-line treatment and to examine the validity of "the Japanese Respiratory Society (JRS) Guidelines for management of HAP".
METHODOLOGY: The observational survey was conducted during the period of June 2002-May 2004 and patients with HAP were prospectively surveyed using the consecutive enrollment method. A total of 1,356 patients from 254 hospitals nationwide were analyzed. Clinical response to first-line antibiotics was evaluated at the end of the medication.
RESULTS: The 30-day mortality rate was 19.8%. Patients were classified into four groups according to the JRS guideline criteria. There were remarkable variances in the number of cases of each group. Mild/moderate pneumonia with no risk factors (group I) accounted for 0.3% of all cases. The mortality rate tended to be higher, as clinical conditions became more serious (group II < III < IV). Alternatively, though categorized in the same group (group III), there was a difference in the mortality rate by the severity of pneumonia (severe cases 32.2% vs. moderate cases 11.0%). First-line medication using carbapenems accounted for 61.7% of total cases. The efficacy rate of guideline-concordant therapy was significantly higher than that of guideline-discordant therapy (54.2% vs. 41.7%).
CONCLUSIONS: This is the first nationwide study on HAP in Japan. The clinical characteristics and prognosis of HAP were elucidated. Review of the current classification of the disease is required and these results provide valuable information for the next revision of the guidelines.

PMID 18277024  Intern Med. 2008;47(4):245-54. Epub 2008 Feb 15.
著者: Kentaro Iwata, Wataru Igarashi, Midori Honjo, Hideaki Oka, Yuichiro Oba, Hiroyuki Yoshida, Goh Ohji, Toshihiko Shimada
雑誌名: J Infect Chemother. 2012 Oct;18(5):734-40. doi: 10.1007/s10156-012-0411-x. Epub 2012 Apr 11.
Abstract/Text The characteristics of hospital-acquired pneumonia (HAP) are not well documented. In the present study we investigated the severity and mortality, microbiological profile, and the value of Gram staining in culture-confirmed HAP in a Japanese hospital by retrospective review conducted at a Japanese university hospital. Only culture-confirmed cases with good specimen quality were included in the analysis. The clinical characteristics of HAP, as well as the causative organisms, were investigated. Furthermore, the prognostic ability of existing prediction rules were evaluated for prediction of overall mortality. Forty-two cases were enrolled in this analysis. The majority of patients were admitted to the ICU (61.9 %), and 40.5 % had ventilator-associated pneumonia (VAP). The 30-day mortality was 23.8 %, which is less than that reported in the United States. Factors commonly known to be associated with worse outcome in the USA did not appear to influence the mortality from HAP in Japan. The most frequent causative organisms were methicillin-resistant Staphylococcus aureus (MRSA), followed by Pseudomonas spp. Sensitivity and negative predictive value of Gram staining were 89.4 and 85.7 %, respectively. SMART-COP predicted 30-day mortality with an area under the ROC curve (AUC) >0.7. The characteristics of HAP in Japan differ from HAP reported in the USA. In addition to lower mortality, we found both fewer ICU cases and VAP. Gram staining of good-quality specimens demonstrated promising sensitivity to predict the causative organisms. SMART-COP predicted mortality with appropriate ROC curve (AUC).

PMID 22491995  J Infect Chemother. 2012 Oct;18(5):734-40. doi: 10.1007・・・
著者: F R Cockerill, J W Wilson, E A Vetter, K M Goodman, C A Torgerson, W S Harmsen, C D Schleck, D M Ilstrup, J A Washington, W R Wilson
雑誌名: Clin Infect Dis. 2004 Jun 15;38(12):1724-30. doi: 10.1086/421087. Epub 2004 May 25.
Abstract/Text The effects of volume of blood, number of consecutive cultures, and incubation time on pathogen recovery were evaluated for 37,568 blood cultures tested with the automated BACTEC 9240 instrument (Becton Dickinson Diagnostic Instrument Systems) at a tertiary care center over the period of 12 June 1996 through 12 October 1997. When the results for this study were compared with previous data published for manual broth-based blood culture systems and patient samples obtained in the 1970s and 1980s, the following were found: (1) the percentage increase in pathogen recovery per milliliter of blood is less, (2) more consecutive blood culture sets over a 24-h period are required to detect bloodstream pathogens, and (3) a shorter duration of incubation is required to diagnose bloodstream infections. Guidelines developed in the 1970s and 1980s for processing and culturing blood may require revision.

PMID 15227618  Clin Infect Dis. 2004 Jun 15;38(12):1724-30. doi: 10.10・・・
著者: Coleman Rotstein, Gerald Evans, Abraham Born, Ronald Grossman, R Bruce Light, Sheldon Magder, Barrie McTaggart, Karl Weiss, George G Zhanel
雑誌名: Can J Infect Dis Med Microbiol. 2008 Jan;19(1):19-53.
Abstract/Text Hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) are important causes of morbidity and mortality, with mortality rates approaching 62%. HAP and VAP are the second most common cause of nosocomial infection overall, but are the most common cause documented in the intensive care unit setting. In addition, HAP and VAP produce the highest mortality associated with nosocomial infection. As a result, evidence-based guidelines were prepared detailing the epidemiology, microbial etiology, risk factors and clinical manifestations of HAP and VAP. Furthermore, an approach based on the available data, expert opinion and current practice for the provision of care within the Canadian health care system was used to determine risk stratification schemas to enable appropriate diagnosis, antimicrobial management and nonantimicrobial management of HAP and VAP. Finally, prevention and risk-reduction strategies to reduce the risk of acquiring these infections were collated. Future initiatives to enhance more rapid diagnosis and to effect better treatment for resistant pathogens are necessary to reduce morbidity and improve survival.

PMID 19145262  Can J Infect Dis Med Microbiol. 2008 Jan;19(1):19-53.
著者: American Thoracic Society, Infectious Diseases Society of America
雑誌名: Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST.
Abstract/Text
PMID 15699079  Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. ・・・
著者: R G Masterton, A Galloway, G French, M Street, J Armstrong, E Brown, J Cleverley, P Dilworth, C Fry, A D Gascoigne, Alan Knox, Dilip Nathwani, Robert Spencer, Mark Wilcox
雑誌名: J Antimicrob Chemother. 2008 Jul;62(1):5-34. doi: 10.1093/jac/dkn162. Epub 2008 Apr 29.
Abstract/Text These evidence-based guidelines have been produced after a systematic literature review of a range of issues involving prevention, diagnosis and treatment of hospital-acquired pneumonia (HAP). Prevention is structured into sections addressing general issues, equipment, patient procedures and the environment, whereas in treatment, the structure addresses the use of antimicrobials in prevention and treatment, adjunctive therapies and the application of clinical protocols. The sections dealing with diagnosis are presented against the clinical, radiological and microbiological diagnosis of HAP. Recommendations are also made upon the role of invasive sampling and quantitative microbiology of respiratory secretions in directing antibiotic therapy in HAP/ventilator-associated pneumonia.

PMID 18445577  J Antimicrob Chemother. 2008 Jul;62(1):5-34. doi: 10.10・・・
著者: Yuji Oba, Tareq Zaza
雑誌名: Radiology. 2010 May;255(2):386-95. doi: 10.1148/radiol.10090946.
Abstract/Text PURPOSE: To systematically examine whether abandoning daily routine chest radiography would adversely affect outcomes, such as mortality and length of stay (LOS), and identify a subgroup in which daily routine chest radiography might be beneficial.
MATERIALS AND METHODS: This was a meta-analysis of clinical trials that examined the effect of abandoning daily routine chest radiography in adults in intensive care units (ICUs). Studies were identified through searches of MEDLINE, Cochrane Database, Database of Abstracts of Reviews of Effects, Biological Abstracts, and CINAHL. The results were expressed as odds ratios (ORs) or weighted mean difference (WMD) along with their 95% confidence intervals (CIs).
RESULTS: Eight studies with a total of 7078 patients were identified. A pooled analysis revealed that the elimination of daily routine chest radiography did not affect either hospital or ICU mortality (OR, 1.02;[95% CI: 0.89, 1.17; P = .78 and OR, 0.92; 95% CI: 0.76, 1.11; P = .4, respectively). There was no significant difference in ICU LOS (WMD = 0.19 days; 95% CI: -0.13, 0.51; P = .25), hospital LOS (WMD = -0.29 days; 95% CI: -0.71, 0.13; P = .18), and ventilator days (WMD = 0.33 days; 95% CI: -0.12, 0.78; P = .15) between the on-demand and daily routine groups. Regression analyses failed to identify any subgroup in which performing daily routine chest radiography was beneficial.
CONCLUSION: Systematic but unselective daily routine chest radiography can likely be eliminated without increasing adverse outcomes in adult patients in ICUs. Further studies are necessary to identify the specific patient population that would benefit from daily routine chest radiographs.

PMID 20413752  Radiology. 2010 May;255(2):386-95. doi: 10.1148/radiol.・・・
著者: T Maruyama, M S Niederman, T Kobayashi, H Kobayashi, T Takagi, C N D'Alessandro-Gabazza, H Fujimoto, P Gil Bernabe, S Hirohata, S Nakayama, K Nishikubo, H Yuda, A Yamaguchi, E C Gabazza, T Noguchi, Y Takei, O Taguchi
雑誌名: Respir Med. 2008 Sep;102(9):1287-95. doi: 10.1016/j.rmed.2008.03.027. Epub 2008 Jul 7.
Abstract/Text There are no prospective comparison of the etiology and clinical outcome between hospital-acquired pneumonia (HAP) and nursing home-acquired pneumonia (NHAP) in non-intubated elderly. This study prospectively evaluated the etiology of HAP and NHAP in non-intubated elderly. A prospective cohort study was carried out in a rural region of Japan where the population over 65 years of age represents 30% of the population. A total of 108 patients were enrolled. There were 33 patients with HAP and 75 with NHAP. Etiologic diagnosis was established in 78.8% of HAP and in 72% of NHAP patients. The most frequent pathogens were Chlamydophila pneumoniae followed by Streptococcus pneumoniae, Staphylococcus aureus and Influenza virus. The frequency of Streptococcus pneumoniae and Influenza virus was significantly higher, whereas the frequency of Staphylococcus aureus and Enterobacteriaceae was significantly lower in NHAP compared to HAP. Performance and nutritional status were significantly worse in patients with HAP than in those with NHAP. Hospital mortality was significantly lower in patients with NHAP compared to those with HAP. This study demonstrated that C. pneumoniae, Streptococcus pneumoniae, Staphylococcus aureus and Influenza virus are frequent causative agents of pneumonia in non-intubated elderly and that the responsible pathogens and clinical outcome differ between NHAP and HAP.

PMID 18602805  Respir Med. 2008 Sep;102(9):1287-95. doi: 10.1016/j.rme・・・
著者: Anna S Levin
雑誌名: Expert Rev Anti Infect Ther. 2009 Feb;7(1):57-68. doi: 10.1586/14787210.7.1.57.
Abstract/Text Legionnaires' disease (LD) can be nosocomial, community acquired or travel related. The source of Legionella infection is potable water systems that become colonized by the microorganism. Prevention studies involved mainly hospital water systems. Different strategies have been suggested but none are fully successful: engineering modifications, heating of water to temperatures above 59 degrees C, heating and flushing the plumbing with hot water (80 degrees C), water chlorination, silver-copper ionization of the water, UV-light disinfection of water, instant heating in order to avoid hot-water tanks and others. LD is widely underdiagnosed because laboratory methods are specific and suspicion index is usually low; therefore, the appropriate tests are not requested. In addition, all methods present limitations. No randomized controlled trials have been performed to study the treatment of legionellosis but comparative observational studies have been published, mostly involving community-acquired cases. Macrolides and quinolones presented similar results when comparing important outcomes, such as mortality and complications.

PMID 19622057  Expert Rev Anti Infect Ther. 2009 Feb;7(1):57-68. doi: ・・・
著者: Liliana Simon, France Gauvin, Devendra K Amre, Patrick Saint-Louis, Jacques Lacroix
雑誌名: Clin Infect Dis. 2004 Jul 15;39(2):206-17. doi: 10.1086/421997. Epub 2004 Jul 2.
Abstract/Text A meta-analysis was performed to evaluate the accuracy of determination of procalcitonin (PCT) and C-reactive protein (CRP) levels for the diagnosis of bacterial infection. The analysis included published studies that evaluated these markers for the diagnosis of bacterial infections in hospitalized patients. PCT level was more sensitive (88% [95% confidence interval [CI], 80%-93%] vs. 75% [95% CI, 62%-84%]) and more specific (81% [95% CI, 67%-90%] vs. 67% [95% CI, 56%-77%]) than CRP level for differentiating bacterial from noninfective causes of inflammation. The Q value for PCT markers was higher (0.82 vs. 0.73). The sensitivity for differentiating bacterial from viral infections was also higher for PCT markers (92% [95% CI, 86%-95%] vs. 86% [95% CI, 65%-95%]); the specificities were comparable (73% [95% CI, 42%-91%] vs. 70% [95% CI, 19%-96%]). The Q value was higher for PCT markers (0.89 vs. 0.83). PCT markers also had a higher positive likelihood ratio and lower negative likelihood ratio than did CRP markers in both groups. On the basis of this analysis, the diagnostic accuracy of PCT markers was higher than that of CRP markers among patients hospitalized for suspected bacterial infections.

PMID 15307030  Clin Infect Dis. 2004 Jul 15;39(2):206-17. doi: 10.1086・・・
著者: Beat Müller, Stephan Harbarth, Daiana Stolz, Roland Bingisser, Christian Mueller, Jörg Leuppi, Charly Nusbaumer, Michael Tamm, Mirjam Christ-Crain
雑誌名: BMC Infect Dis. 2007 Mar 2;7:10. doi: 10.1186/1471-2334-7-10. Epub 2007 Mar 2.
Abstract/Text BACKGROUND: Community-acquired pneumonia (CAP) is the most frequent infection-related cause of death. The reference standard to diagnose CAP is a new infiltrate on chest radiograph in the presence of recently acquired respiratory signs and symptoms. This study aims to evaluate the diagnostic and prognostic accuracy of clinical signs and symptoms and laboratory biomarkers for CAP.
METHODS: 545 patients with suspected lower respiratory tract infection, admitted to the emergency department of a university hospital were included in a pre-planned post-hoc analysis of two controlled intervention trials. Baseline assessment included history, clinical examination, radiography and measurements of procalcitonin (PCT), highly sensitive C-reactive protein (hsCRP) and leukocyte count.
RESULTS: Of the 545 patients, 373 had CAP, 132 other respiratory tract infections, and 40 other final diagnoses. The AUC of a clinical model including standard clinical signs and symptoms (i.e. fever, cough, sputum production, abnormal chest auscultation and dyspnea) to diagnose CAP was 0.79 [95% CI, 0.75-0.83]. This AUC was significantly improved by including PCT and hsCRP (0.92 [0.89-0.94]; p < 0.001). PCT had a higher diagnostic accuracy (AUC, 0.88 [0.84-0.93]) in differentiating CAP from other diagnoses, as compared to hsCRP (AUC, 0.76 [0.69-0.83]; p < 0.001) and total leukocyte count (AUC, 0.69 [0.62-0.77]; p < 0.001). To predict bacteremia, PCT had a higher AUC (0.85 [0.80-0.91]) as compared to hsCRP (p = 0.01), leukocyte count (p = 0.002) and elevated body temperature (p < 0.001). PCT, in contrast to hsCRP and leukocyte count, increased with increasing severity of CAP, as assessed by the pneumonia severity index (p < 0.001).
CONCLUSION: PCT, and to a lesser degree hsCRP, improve the accuracy of currently recommended approaches for the diagnosis of CAP, thereby complementing clinical signs and symptoms. PCT is useful in the severity assessment of CAP.

PMID 17335562  BMC Infect Dis. 2007 Mar 2;7:10. doi: 10.1186/1471-2334・・・
著者: Lila Bouadma, Charles-Edouard Luyt, Florence Tubach, Christophe Cracco, Antonio Alvarez, Carole Schwebel, Frédérique Schortgen, Sigismond Lasocki, Benoît Veber, Monique Dehoux, Maguy Bernard, Blandine Pasquet, Bernard Régnier, Christian Brun-Buisson, Jean Chastre, Michel Wolff, PRORATA trial group
雑誌名: Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25.
Abstract/Text BACKGROUND: Reduced duration of antibiotic treatment might contain the emergence of multidrug-resistant bacteria in intensive care units. We aimed to establish the effectiveness of an algorithm based on the biomarker procalcitonin to reduce antibiotic exposure in this setting.
METHODS: In this multicentre, prospective, parallel-group, open-label trial, we used an independent, computer-generated randomisation sequence to randomly assign patients in a 1:1 ratio to procalcitonin (n=311 patients) or control (n=319) groups; investigators were masked to assignment before, but not after, randomisation. For the procalcitonin group, antibiotics were started or stopped based on predefined cut-off ranges of procalcitonin concentrations; the control group received antibiotics according to present guidelines. Drug selection and the final decision to start or stop antibiotics were at the discretion of the physician. Patients were expected to stay in the intensive care unit for more than 3 days, had suspected bacterial infections, and were aged 18 years or older. Primary endpoints were mortality at days 28 and 60 (non-inferiority analysis), and number of days without antibiotics by day 28 (superiority analysis). Analyses were by intention to treat. The margin of non-inferiority was 10%. This trial is registered with ClinicalTrials.gov, number NCT00472667.
FINDINGS: Nine patients were excluded from the study; 307 patients in the procalcitonin group and 314 in the control group were included in analyses. Mortality of patients in the procalcitonin group seemed to be non-inferior to those in the control group at day 28 (21.2% [65/307] vs 20.4% [64/314]; absolute difference 0.8%, 90% CI -4.6 to 6.2) and day 60 (30.0% [92/307] vs 26.1% [82/314]; 3.8%, -2.1 to 9.7). Patients in the procalcitonin group had significantly more days without antibiotics than did those in the control group (14.3 days [SD 9.1] vs 11.6 days [SD 8.2]; absolute difference 2.7 days, 95% CI 1.4 to 4.1, p<0.0001).
INTERPRETATION: A procalcitonin-guided strategy to treat suspected bacterial infections in non-surgical patients in intensive care units could reduce antibiotic exposure and selective pressure with no apparent adverse outcomes.
FUNDING: Assistance Publique-Hôpitaux de Paris, France, and Brahms, Germany.

Copyright 2010 Elsevier Ltd. All rights reserved.
PMID 20097417  Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140・・・
著者: Philipp Schuetz, Mirjam Christ-Crain, Robert Thomann, Claudine Falconnier, Marcel Wolbers, Isabelle Widmer, Stefanie Neidert, Thomas Fricker, Claudine Blum, Ursula Schild, Katharina Regez, Ronald Schoenenberger, Christoph Henzen, Thomas Bregenzer, Claus Hoess, Martin Krause, Heiner C Bucher, Werner Zimmerli, Beat Mueller, ProHOSP Study Group
雑誌名: JAMA. 2009 Sep 9;302(10):1059-66. doi: 10.1001/jama.2009.1297.
Abstract/Text CONTEXT: In previous smaller trials, a procalcitonin (PCT) algorithm reduced antibiotic use in patients with lower respiratory tract infections (LRTIs).
OBJECTIVE: To examine whether a PCT algorithm can reduce antibiotic exposure without increasing the risk for serious adverse outcomes.
DESIGN, SETTING, AND PATIENTS: A multicenter, noninferiority, randomized controlled trial in emergency departments of 6 tertiary care hospitals in Switzerland with an open intervention of 1359 patients with mostly severe LRTIs randomized between October 2006 and March 2008.
INTERVENTION: Patients were randomized to administration of antibiotics based on a PCT algorithm with predefined cutoff ranges for initiating or stopping antibiotics (PCT group) or according to standard guidelines (control group). Serum PCT was measured locally in each hospital and instructions were Web-based.
MAIN OUTCOME MEASURES: Noninferiority of the composite adverse outcomes of death, intensive care unit admission, disease-specific complications, or recurrent infection requiring antibiotic treatment within 30 days, with a predefined noninferiority boundary of 7.5%; and antibiotic exposure and adverse effects from antibiotics.
RESULTS: The rate of overall adverse outcomes was similar in the PCT and control groups (15.4% [n = 103] vs 18.9% [n = 130]; difference, -3.5%; 95% CI, -7.6% to 0.4%). The mean duration of antibiotics exposure in the PCT vs control groups was lower in all patients (5.7 vs 8.7 days; relative change, -34.8%; 95% CI, -40.3% to -28.7%) and in the subgroups of patients with community-acquired pneumonia (n = 925, 7.2 vs 10.7 days; -32.4%; 95% CI, -37.6% to -26.9%), exacerbation of chronic obstructive pulmonary disease (n = 228, 2.5 vs 5.1 days; -50.4%; 95% CI, -64.0% to -34.0%), and acute bronchitis (n = 151, 1.0 vs 2.8 days; -65.0%; 95% CI, -84.7% to -37.5%). Antibiotic-associated adverse effects were less frequent in the PCT group (19.8% [n = 133] vs 28.1% [n = 193]; difference, -8.2%; 95% CI, -12.7% to -3.7%).
CONCLUSION: In patients with LRTIs, a strategy of PCT guidance compared with standard guidelines resulted in similar rates of adverse outcomes, as well as lower rates of antibiotic exposure and antibiotic-associated adverse effects.
TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN95122877.

PMID 19738090  JAMA. 2009 Sep 9;302(10):1059-66. doi: 10.1001/jama.200・・・
著者: James D Chalmers, Aran Singanayagam, Adam T Hill
雑誌名: Am J Med. 2008 Mar;121(3):219-25. doi: 10.1016/j.amjmed.2007.10.033.
Abstract/Text BACKGROUND: C-reactive protein (CRP) is an acute phase protein synthesized by the liver primarily in response to interleukin-6. Initial studies have suggested that inflammatory markers may have a role in predicting severity. We investigated whether admission and day 4 CRP could predict severity in community-acquired pneumonia.
METHODS: A prospective study was carried out over a 2-year period in a large teaching hospital. CRP was measured on admission and on day 4. The outcomes of interest were: 30-day mortality; need for mechanical ventilation and/or inotropic support; development of complicated pneumonia (lung abscess, empyema, or complicated parapneumonic effusion); the value of predictive tests were assessed using multivariate logistic regression.
RESULTS: There were 570 patients included in the study; 30-day mortality was 9.6%. Low CRP levels showed a high negative predictive value for excluding 30-day mortality (CRP <10 mg/L=100%, CRP <50=99.1%, CRP <100=98.9%, CRP <200=94.9%). Low admission CRP levels <100 mg/L were independently associated with reduced 30-day mortality (odds ratio [OR] 0.18; 0.04-0.85), P=.03; need for mechanical ventilation and/or inotropic support (OR 0.21; 0.14-0.4), P=.002; and complicated pneumonia (OR 0.05; 0.01-0.35), P=.003. A CRP that fails to fall by 50% or more within 4 days of admission is independently associated with increased 30 day mortality (OR 24.5; 6.4-93.4), P <.0001; need for mechanical ventilation and/or inotropic support (OR 7.1; 2.8-17.8), P <.0001 and complicated pneumonia (OR 15.4; 6.32-37.6), P <.0001.
CONCLUSIONS: Admission CRP <100 mg/L has reduced risk for 30-day mortality, need for mechanical ventilation and/or inotropic support, and complicated pneumonia. Failure of CRP to fall by 50% or more at day 4 leads to an increased risk for 30-day mortality, need for mechanical ventilation and/or inotropic support, and complicated pneumonia. C-reactive protein is an independent marker of severity in community-acquired pneumonia.

PMID 18328306  Am J Med. 2008 Mar;121(3):219-25. doi: 10.1016/j.amjmed・・・
著者: Kentaro Iwata, Hiroki Kagawa
雑誌名: Am J Med. 2008 Dec;121(12):e7; author reply e9. doi: 10.1016/j.amjmed.2008.07.006.
Abstract/Text
PMID 19028189  Am J Med. 2008 Dec;121(12):e7; author reply e9. doi: 10・・・
著者: Renato Seligman, Luis Francisco Ramos-Lima, Vivian do Amaral Oliveira, Carina Sanvicente, Juliana Sartori, Elyara Fiorin Pacheco
雑誌名: J Bras Pneumol. 2013 May-Jun;39(3):339-48. doi: 10.1590/S1806-37132013000300011.
Abstract/Text OBJECTIVE: To identify risk factors for the development of hospital-acquired pneumonia (HAP) caused by multidrug-resistant (MDR) bacteria in non-ventilated patients.
METHODS: This was a retrospective observational cohort study conducted over a three-year period at a tertiary-care teaching hospital. We included only non-ventilated patients diagnosed with HAP and presenting with positive bacterial cultures. Categorical variables were compared with chi-square test. Logistic regression analysis was used to determine risk factors for HAP caused by MDR bacteria.
RESULTS: Of the 140 patients diagnosed with HAP, 59 (42.1%) were infected with MDR strains. Among the patients infected with methicillin-resistant Staphylococcus aureus and those infected with methicillin-susceptible S. aureus, mortality was 45.9% and 50.0%, respectively (p = 0.763). Among the patients infected with MDR and those infected with non-MDR gram-negative bacilli, mortality was 45.8% and 38.3%, respectively (p = 0.527). Univariate analysis identified the following risk factors for infection with MDR bacteria: COPD; congestive heart failure; chronic renal failure; dialysis; urinary catheterization; extrapulmonary infection; and use of antimicrobial therapy within the last 10 days before the diagnosis of HAP. Multivariate analysis showed that the use of antibiotics within the last 10 days before the diagnosis of HAP was the only independent predictor of infection with MDR bacteria (OR = 3.45; 95% CI: 1.56-7.61; p = 0.002).
CONCLUSIONS: In this single-center study, the use of broad-spectrum antibiotics within the last 10 days before the diagnosis of HAP was the only independent predictor of infection with MDR bacteria in non-ventilated patients with HAP.

PMID 23857697  J Bras Pneumol. 2013 May-Jun;39(3):339-48. doi: 10.1590・・・
著者: Allan J Walkey, Max R O'Donnell, Renda Soylemez Wiener
雑誌名: Chest. 2011 May;139(5):1148-55. doi: 10.1378/chest.10-1556. Epub 2010 Sep 23.
Abstract/Text BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) is an important cause of nosocomial pneumonia. Societal guidelines suggest linezolid may be the preferred treatment of MRSA nosocomial pneumonia. We investigated the efficacy of linezolid compared with glycopeptide antibiotics (vancomycin or teicoplanin) for nosocomial pneumonia.
METHODS: This was a systematic review and meta-analysis of English language, randomized, controlled trials comparing linezolid to glycopeptide antibiotics for suspected MRSA pneumonia in subjects > 12 years of age. A highly sensitive search of PubMed MEDLINE and Cochrane Central Register of Controlled Trials databases identified relevant studies.
RESULTS: Eight trials encompassing 1,641 subjects met entry criteria. Linezolid was not superior to glycopeptide antibiotics for end points of clinical success (relative risk [RR] linezolid vs glycopeptide, 1.04; 95% CI, 0.97-1.11; P = .28), microbiologic success (RR, 1.13; 95% CI, 0.97-1.31; P = .12), or mortality (RR, 0.91; 95% CI, 0.69-1.18; P = .47). In addition, clinical success in the subgroup of subjects with MRSA-positive respiratory tract culture (RR, 1.23; 95% CI, 0.97-1.57; P = .09) was not significantly different from those without MRSA (RR, 0.95; 95% CI, 0.83-1.09; P = .48), P for interaction, 0.07. The risk for adverse events was not different between the two antibiotic classes (RR, 0.96; 95% CI, 0.86-1.07; P = .48).
CONCLUSION: Randomized controlled trials do not support superiority of linezolid over glycopeptide antibiotics for the treatment of nosocomial pneumonia. We recommend that decisions between linezolid or glycopeptide antibiotics for empirical or MRSA-directed therapy of nosocomial pneumonia depend on local availability, antibiotic resistance patterns, preferred routes of delivery, and cost, rather than presumed differences in efficacy.

PMID 20864609  Chest. 2011 May;139(5):1148-55. doi: 10.1378/chest.10-1・・・
著者: Leonardo Lorente, Lisset Lorenzo, María M Martín, Alejandro Jiménez, María L Mora
雑誌名: Ann Pharmacother. 2006 Feb;40(2):219-23. doi: 10.1345/aph.1G467. Epub 2006 Jan 31.
Abstract/Text BACKGROUND: It is known that beta-lactam antibiotics exhibit time-dependent bactericidal activity. Several studies have found continuous infusion of meropenem more effective than intermittent infusion in maintaining constant serum concentrations in excess of the minimum inhibitory concentration. However, limited data exist on the clinical efficacy of meropenem administered by continuous infusion.
OBJECTIVE: To evaluate the clinical efficacy of continuous versus intermittent infusion of meropenem for the treatment of ventilator-associated pneumonia (VAP) due to gram-negative bacilli.
METHODS: A retrospective cohort study was conducted of patients with VAP caused by gram-negative bacilli who received initial empiric antibiotic therapy with meropenem. We analyzed 2 contemporary cohorts: one group received meropenem by continuous infusion (1 g over 360 min every 6 h), the other by intermittent infusion (1 g over 30 min every 6 h). The administration method was prescribed according to the physician's discretion. Patients received meropenem plus tobramycin for 14 days.
RESULTS: There were no significant differences between patient groups with regard to gender, age, APACHE-II at intensive care unit admission, diagnosis, microorganism responsible for VAP, or organ dysfunction severity at the time VAP was suspected. The group receiving medication by continuous infusion showed a greater clinical cure rate than the group treated with intermittent infusion (38 of 42, 90.47%, vs 28 of 47, 59.57%, respectively, with OR 6.44 [95% CI 1.97 to 21.05; p < 0.001]).
CONCLUSIONS: Meropenem administered by continuous infusion may have more clinical efficacy than intermittent infusion.

PMID 16449546  Ann Pharmacother. 2006 Feb;40(2):219-23. doi: 10.1345/a・・・
著者: Mical Paul, Ishay Benuri-Silbiger, Karla Soares-Weiser, Leonard Leibovici
雑誌名: BMJ. 2004 Mar 20;328(7441):668. doi: 10.1136/bmj.38028.520995.63. Epub 2004 Mar 2.
Abstract/Text OBJECTIVE: To compare beta lactam monotherapy with beta lactam-aminoglycoside combination therapy for severe infections.
DATA SOURCES: Medline, Embase, Lilacs, Cochrane Library, and conference proceedings, to 2003; references of included studies; contact with all authors. No restrictions, such as language, year of publication, or publication status.
STUDY SELECTION: All randomised trials of beta lactam monotherapy compared with beta lactam-aminoglycoside combination therapy for patients without neutropenia who fulfilled criteria for sepsis.
DATA SELECTION: Two reviewers independently applied selection criteria, performed quality assessment, and extracted the data. The primary outcome assessed was all cause fatality by intention to treat. Relative risks were pooled with the random effect model (relative risk < 1 favours monotherapy).
RESULTS: 64 trials with 7586 patients were included. There was no difference in all cause fatality (relative risk 0.90, 95% confidence interval 0.77 to 1.06). 12 studies compared the same beta lactam (1.02, 0.76 to 1.38), and 31 studies compared different beta lactams (0.85, 0.69 to 1.05). Clinical failure was more common with combination treatment overall (0.87, 0.78 to 0.97) and among studies comparing different beta lactams (0.76, 0.68 to 0.86). There was no advantage to combination therapy among patients with Gram negative infections (1835 patients) or Pseudomonas aeruginosa infections (426 patients). There was no difference in the rate of development of resistance. Nephrotoxicity was significantly more common with combination therapy (0.36, 0.28 to 0.47). Heterogeneity was not significant for these comparisons.
CONCLUSIONS: In the treatment of sepsis the addition of an aminoglycoside to beta lactams should be discouraged. Fatality remains unchanged, while the risk for adverse events is increased.

PMID 14996699  BMJ. 2004 Mar 20;328(7441):668. doi: 10.1136/bmj.38028.・・・
著者: F Alvarez-Lerma
雑誌名: Intensive Care Med. 1996 May;22(5):387-94.
Abstract/Text OBJECTIVE: To assess the frequency of and the reasons for changing empiric antibiotics during the treatment of pneumonia acquired in the intensive care unit (ICU).
DESIGN: A prospective multicenter study of 1 year's duration.
SETTING: Medical and surgical ICUs in 30 hospitals all over Spain.
PATIENTS: Of a total of 16,872 patients initially enrolled into the study, 530 patients developed 565 episodes of pneumonia after admission to the ICU.
RESULTS: Empiric antibiotics were administered in 490 (86.7%) of the 565 episodes of pneumonia. The antimicrobials most frequently used were amikacin in 120 cases, tobramycin in 110, ceftazidime in 96, and cefotaxime in 96. Monotherapy was indicated in 135 (27.6%) of the 490 episodes, a combination of two antibiotics in 306 episodes (62.4%), and a combination of three antibiotics in 49 episodes (10%). The empiric antibiotic treatment was modified in 214 (43.7%) cases because of isolation of a microorganism not covered by treatment in 133 (62.1%) cases, lack of clinical response in 77 (36%), and development of resistance in 14 (6.6%). Individual factors associated with modification of empiric treatment identified in the multivariate analysis were microorganism not covered (relative risk (RR)) 22.02; 95% confidence interval (CI) 11.54 to 42.60; p < 0.0001), administration of more than one antimicrobial (RR 1.29; 95% CI 1.02 to 1.65; p = 0.021), and previous use of antibiotics (RR 1.22; 95% CI 1.08 to 1.39; p = 0.0018). Attributable mortality was 16.2% in patients with appropriate initial therapy and 24.7% in patients with inappropriate treatment (p = 0.034).
CONCLUSIONS: A high percentage of patients (43.7%) required modification of empiric antibiotic treatment for pneumonia acquired in the ICU. In 62.1% of cases the main reason for changing antibiotic treatment was inadequate antibiotic coverage of microorganisms. Attributable mortality was significantly higher in patients with inappropriate initial antibiotic therapy. Rapid and accurate diagnostic methods are needed to initiate appropriate antibiotic treatment as soon as pneumonia is suspected.

PMID 8796388  Intensive Care Med. 1996 May;22(5):387-94.
著者: Ethan Rubinstein, Tahaniyat Lalani, G Ralph Corey, Zeina A Kanafani, Esteban C Nannini, Marcelo G Rocha, Galia Rahav, Michael S Niederman, Marin H Kollef, Andrew F Shorr, Patrick C Lee, Arnold L Lentnek, Carlos M Luna, Jean-Yves Fagon, Antoni Torres, Michael M Kitt, Fredric C Genter, Steven L Barriere, H David Friedland, Martin E Stryjewski, ATTAIN Study Group
雑誌名: Clin Infect Dis. 2011 Jan 1;52(1):31-40. doi: 10.1093/cid/ciq031.
Abstract/Text BACKGROUND: Telavancin is a lipoglycopeptide bactericidal against gram-positive pathogens.
METHODS: Two methodologically identical, double-blind studies (0015 and 0019) were conducted involving patients with hospital-acquired pneumonia (HAP) due to gram-positive pathogens, particularly methicillin-resistant Staphylococcus aureus (MRSA). Patients were randomized 1:1 to telavancin (10 mg/kg every 24 h) or vancomycin (1 g every 12 h) for 7-21 days. The primary end point was clinical response at follow-up/test-of-cure visit.
RESULTS: A total of 1503 patients were randomized and received study medication (the all-treated population). In the pooled all-treated population, cure rates with telavancin versus vancomycin were 58.9% versus 59.5% (95% confidence interval [CI] for the difference, -5.6% to 4.3%). In the pooled clinically evaluable population (n = 654), cure rates were 82.4% with telavancin and 80.7% with vancomycin (95% CI for the difference, -4.3% to 7.7%). Treatment with telavancin achieved higher cure rates in patients with monomicrobial S. aureus infection and comparable cure rates in patients with MRSA infection; in patients with mixed gram-positive/gram-negative infections, cure rates were higher in the vancomycin group. Incidence and types of adverse events were comparable between the treatment groups. Mortality rates for telavancin-treated versus vancomycin-treated patients were 21.5% versus 16.6% (95% CI for the difference, -0.7% to 10.6%) for study 0015 and 18.5% versus 20.6% (95% CI for the difference, -7.8% to 3.5%) for study 0019. Increases in serum creatinine level were more common in the telavancin group (16% vs 10%).
CONCLUSIONS: The primary end point of the studies was met, indicating that telavancin is noninferior to vancomycin on the basis of clinical response in the treatment of HAP due to gram-positive pathogens.

PMID 21148517  Clin Infect Dis. 2011 Jan 1;52(1):31-40. doi: 10.1093/c・・・
著者: Antonio T Freire, Vasyl Melnyk, Min Ja Kim, Oleksiy Datsenko, Oleksandr Dzyublik, Felix Glumcher, Yin-Ching Chuang, Robert T Maroko, Gary Dukart, C Angel Cooper, Joan M Korth-Bradley, Nathalie Dartois, Hassan Gandjini, 311 Study Group
雑誌名: Diagn Microbiol Infect Dis. 2010 Oct;68(2):140-51. doi: 10.1016/j.diagmicrobio.2010.05.012.
Abstract/Text To compare efficacy and safety of a tigecycline regimen with an imipenem/cilastatin regimen in hospital-acquired pneumonia patients, a phase 3, multicenter, randomized, double-blind, study evaluated 945 patients. Coprimary end points were clinical response in clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) populations at test-of-cure. Cure rates were 67.9% for tigecycline and 78.2% for imipenem (CE patients) and 62.7% and 67.6% (c-mITT patients), respectively. A statistical interaction occurred between ventilator-associated pneumonia (VAP) and non-VAP subgroups, with significantly lower cure rates in tigecycline VAP patients compared to imipenem; in non-VAP patients, tigecycline was noninferior to imipenem. Overall mortality did not differ between the tigecycline (14.1%) and imipenem regimens (12.2%), although more deaths occurred in VAP patients treated with tigecycline than imipenem. Overall, the tigecycline regimen was noninferior to the imipenem/cilastatin regimen for the c-mITT but not the CE population; this difference appears to have been driven by results in VAP patients.

Copyright © 2010. Published by Elsevier Inc.
PMID 20846586  Diagn Microbiol Infect Dis. 2010 Oct;68(2):140-51. doi:・・・
著者: G Höffken, J Barth, E Rubinstein, H Beckmann, HAP study group
雑誌名: Infection. 2007 Dec;35(6):414-20. doi: 10.1007/s15010-007-6193-x. Epub 2007 Nov 22.
Abstract/Text BACKGROUND: Empiric treatment of hospital-acquired pneumonia (HAP) should be focused on the suspected pathogens. We evaluated the efficacy and safety of moxifloxacin vs ceftriaxone in patients with HAP without risk of infections with Pseudomonas aeruginosa and other non-fermentative Gram-negative bacteria.
PATIENTS AND METHODS: We performed a prospective, randomized, non-blind, multicentric and multinational study to compare the efficacy and safety of moxifloxacin 400 mg IV once daily followed by oral moxifloxacin 400 mg once daily to ceftriaxone 2 g IV once daily followed by oral cefuroxime axetil 500 mg twice daily to treat mild-to-moderate HAP in adult patients requiring initial parenteral therapy. The primary efficacy variable was clinical response 7-10 days after the end of a 7-14-day treatment period, secondary endpoints included clinical and bacteriologic response at different intervals for up to 31 days after treatment. The trial was terminated prematurely due to slow patient recruitment.
RESULTS: A total of 161 subjects (87 men, 74 women) between 18 and 95 years of age were enrolled, 120 of whom were eligible for per protocol efficacy analyses (60 each in the moxifloxacin and the comparator groups). Clinical success rates were 87% for moxifloxacin and 83% for the comparator [95% CI (-9.77 to 15.96%)]. The results for secondary endpoints were comparable between groups. Both treatments were safe and well tolerated.
CONCLUSION: Moxifloxacin IV/oral can be considered as a possible alternative for the antibiotic treatment of patients with mild-to-moderate nosocomial pneumonia without risk factors for highly resistant microorganisms.

PMID 18034211  Infection. 2007 Dec;35(6):414-20. doi: 10.1007/s15010-0・・・
著者: S V Yakovlev, L S Stratchounski, G L Woods, B Adeyi, K A McCarroll, J A Ginanni, I R Friedland, C A Wood, M J DiNubile
雑誌名: Eur J Clin Microbiol Infect Dis. 2006 Oct;25(10):633-41. doi: 10.1007/s10096-006-0193-0.
Abstract/Text The study presented here compared the efficacy and safety of ertapenem and cefepime as initial treatment for adults with pneumonia acquired in skilled-care facilities or in hospital environments outside the intensive care unit (ICU). Non-ventilated patients developing pneumonia in hospital environments outside the ICU, in nursing homes, or in other skilled-care facilities were enrolled in this double-blind non-inferiority study, stratified by APACHE II score (15) and randomized (1:1) to receive cefepime (2 g every 12 h with optional metronidazole 500 mg every 12 h) or ertapenem (1 g daily). After 3 days of parenteral therapy, participants demonstrating clinical improvement could be switched to oral ciprofloxacin or another appropriate oral agent. Probable pathogens were identified in 162 (53.5%) of the 303 randomized participants. The most common pathogens were Enterobacteriaceae, Streptococcus pneumoniae, and Staphylococcus aureus, isolated from 59 (19.5%), 39 (12.9%), and 35 (11.6%) participants, respectively. At the test-of-cure assessment 7-14 days after completion of all study therapy, pneumonia had resolved or substantially improved in 89 (87.3%) of 102 clinically evaluable ertapenem recipients and 80 (86%) of 93 clinically evaluable cefepime recipients (95% confidence interval for the difference, -9.4 to 11.8%), fulfilling pre-specified criteria for statistical non-inferiority. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this study population, ertapenem was as well-tolerated and efficacious as cefepime for the initial treatment of pneumonia acquired in skilled-care facilities or in hospital environments outside the ICU.

PMID 17024505  Eur J Clin Microbiol Infect Dis. 2006 Oct;25(10):633-41・・・
著者: J J Schentag, A J Vari, N E Winslade, D J Swanson, I L Smith, G W Simons, A Vigano
雑誌名: Am J Med. 1985 Feb 8;78(2A):34-41.
Abstract/Text During the course of one year, 47 critical care patients with gram-negative bacillary pneumonia at Millard Fillmore Hospital were randomly assigned to aztreonam or tobramycin therapy (two to one). Of these, 40 were fully evaluable for microbiologic and clinical response. All evaluable patients had gram-negative organisms in tracheal aspirate culture specimens and confirmed susceptibility of the organism to both study drugs. There was no difference between the two groups with respect to the percentage of patients who received concurrent antibiotics for gram-positive organisms. More than 60 percent of the patients received mechanical ventilation. Essentially, all had new lung infiltrates as shown by chest radiography, leukocytosis, recent onset of fever, and increased volume of purulent secretions. Half had multilobar pulmonary infiltrates. Their mean age was 73 years, with none under age 50. Most had chronic obstructive pulmonary disease, congestive heart failure, or both. By the prognostic nutritional index criteria, over 70 percent were nutritionally deficient at entry. The majority of infections were caused by Pseudomonas, Enterobacter, Klebsiella, and Escherichia coli. Aztreonam eradicated 92 percent of the causative gram-negative organisms, compared with 57 percent for tobramycin (p less than 0.05). Aztreonam produced a favorable clinical response (cure or improvement) in 93 percent of patients, compared with 50 percent for tobramycin (p less than 0.05). There were no differences in the minor adverse effects observed in the two treatment groups. Overall, aztreonam was superior to tobramycin for treatment of pneumonia due to susceptible gram-negative bacteria in these critical care patients.

PMID 3881947  Am J Med. 1985 Feb 8;78(2A):34-41.
著者: M Fernández-Guerrero, F Gudiol, A Rodriguez-Torres, C Arnau, L Valdés, C Vallvé
雑誌名: Infection. 1991;19 Suppl 6:S320-5.
Abstract/Text In a multicentre clinical trial involving 32 hospitals, 588 adult patients diagnosed with nosocomial pneumonia and not receiving mechanical ventilation were treated randomly with monotherapy with cefotaxime or the antibiotic combination routinely used in each particular hospital. Both groups of patients were similar regarding demographic data, concurrent diseases, additional therapies and causative organism. Protocol violations were recorded in 40 patients, and these patients were excluded from the evaluation of treatment efficacy. The cure rate was 79% in the cefotaxime group and 71% in the group receiving antibiotic combinations; this difference is statistically significant (p = 0.03, Fisher's two-tailed test). In the patients receiving combinations of cephalosporins having activity predominantly against gram-positive organisms plus aminoglycosides, the cure rate obtained was very low. The frequency of serious adverse reactions was significantly higher in the group treated with antibiotic combinations. It is concluded that monotherapy with cefotaxime is the regimen that offers better results for the empirical treatment of nosocomial pneumonia.

PMID 1791077  Infection. 1991;19 Suppl 6:S320-5.
著者: A I Hoepelman, H Kieft, M Aoun, J Kosmidis, T Strand, J Verhoef, S H Gillespie, J Riddell, G Varghese, F Meunier
雑誌名: J Antimicrob Chemother. 1993 Nov;32 Suppl B:175-86.
Abstract/Text In this randomized multicentre study, we compared the safety and efficacy of cefepime, 2.0 g bd i.v., with that of ceftazidime, 2.0 g tid i.v., as initial treatment of adult patients with serious infections of bacterial aetiology. Three hundred and forty-eight patients were entered into the study, 173 received cefepime and 175 ceftazidime. The treatment groups were comparable with respect to demographic characteristics, including the types of infection (cefepime/ceftazidime: urinary tract, 55/72; lower respiratory tract, 83/74; skin and soft tissue, 23/14; septicaemia, 81/81; and others, 15/5). Gram-positive bacteria were identified as pathogens on 86 occasions (cefepime/ceftazidime: 48/41), including 20 Staphylococcus aureus isolates (13/7) and 27 Streptococcus pneumoniae isolates (14/13). Gram-negative bacilli were isolated on 261 occasions (126/135), and included 219 Enterobacteriaceae (cefepime/ceftazidime: 108/111) and 34 strains of Pseudomonas aeruginosa (14/20). An intention-to-treat analysis revealed satisfactory clinical response rates of 80% and 79% for the cefepime and ceftazidime groups, respectively, and bacteriological eradication rates of 85% and 88% for the cefepime and ceftazidime groups, respectively. Of patients with microbiologically documented infections, 86% (84 of 98) treated with cefepime and 87% (94 of 108) treated with ceftazidime responded satisfactorily. Thirty-two patients (19%) treated with cefepime and 26 (15%) treated with ceftazidime died. Thirty-six patients in the cefepime group and 23 in the ceftazidime group experienced adverse events; therapy was discontinued prematurely in four and two patients in the cefepime and ceftazidime groups, respectively. Of the patients experiencing adverse events, 22 (13%) treated with cefepime developed intolerance at the injection site, compared with 11 (6%) treated with ceftazidime (P = 0.045). In conclusion, twice-daily cefepime (2 g bd) is at least as effective as ceftazidime (2 g tid), as initial empirical therapy for serious bacterial infections in non-neutropenic patients.

PMID 8150761  J Antimicrob Chemother. 1993 Nov;32 Suppl B:175-86.
著者: C Jaccard, N Troillet, S Harbarth, G Zanetti, D Aymon, R Schneider, R Chiolero, B Ricou, J Romand, O Huber, P Ambrosetti, G Praz, D Lew, J Bille, M P Glauser, A Cometta
雑誌名: Antimicrob Agents Chemother. 1998 Nov;42(11):2966-72.
Abstract/Text Nosocomial pneumonia and acute peritonitis may be caused by a wide array of pathogens, and combination therapy is often recommended. We have previously shown that imipenem-cilastatin monotherapy was as efficacious as the combination of imipenem-cilastatin plus netilmicin in these two settings. The efficacy of imipenem-cilastatin is now compared to that of piperacillin-tazobactam as monotherapy in patients with nosocomial pneumonia or acute peritonitis. Three hundred seventy one patients with nosocomial pneumonia or peritonitis were randomly assigned to receive either imipenem-cilastatin (0.5 g four times a day) or piperacillin-tazobactam (4.5 g three times a day). Three hundred thirteen were assessable (154 with nosocomial pneumonia and 159 with peritonitis). For nosocomial pneumonia, clinical-failure rates in the piperacillin-tazobactam group (13 of 75 [17%]) and in the imipenem-cilastatin group (23 of 79 [29%]) were similar (P = 0.09), as were the numbers of deaths due to infection (6 in the imipenem-cilastatin group [8%], 7 in the piperacillin-tazobactam group [9%]) (P = 0.78). For acute peritonitis, clinical success rates were comparable (piperacillin-tazobactam, 72 of 76 [95%]; imipenem-cilastatin, 77 of 83 [93%]). For infections due to Pseudomonas aeruginosa, 45 patients had nosocomial pneumonia (21 in the piperacillin-tazobactam group and 24 in the imipenem-cilastatin group) and 10 had peritonitis (5 in each group). In the patients with nosocomial pneumonia, clinical failure was less frequent in the piperacillin-tazobactam group (2 of 21 [10%]) than in the imipenem-cilastatin [corrected] group (12 of 24 [50%]) (P = 0.004). Bacterial resistance to allocated regimen was the main cause of clinical failure (1 in the piperacillin-tazobactam group and 12 in the imipenem-cilastatin group). For the patients with peritonitis, no difference in clinical outcome was observed (five of five cured in each group). The overall frequencies of adverse events related to treatment in the two groups were similar (24 in the piperacillin-tazobactam group, 22 in the imipenem-cilastatin group). Diarrhea was significantly more frequent in the piperacillin-tazobactam group (10 of 24) than in the imipenem-cilastatin group (2 of 22). This study suggests that piperacillin-tazobactam monotherapy is at least as effective and safe as imipenem-cilastatin monotherapy in the treatment of nosocomial pneumonia or peritonitis. In P. aeruginosa pneumonia, piperacillin-tazobactam achieved a better clinical efficacy than imipenem-cilastatin, due to reduced development of microbiological resistance. Tolerance was comparable, with the exception of diarrhea, which was more frequent with piperacillin-tazobactam.

PMID 9797234  Antimicrob Agents Chemother. 1998 Nov;42(11):2966-72.
著者: Richard G Wunderink, Michael S Niederman, Marin H Kollef, Andrew F Shorr, Mark J Kunkel, Alice Baruch, William T McGee, Arlene Reisman, Jean Chastre
雑誌名: Clin Infect Dis. 2012 Mar 1;54(5):621-9. doi: 10.1093/cid/cir895. Epub 2012 Jan 12.
Abstract/Text BACKGROUND: Post hoc analyses of clinical trial data suggested that linezolid may be more effective than vancomycin for treatment of methicillin-resistant Staphylococcus aureus (MRSA) nosocomial pneumonia. This study prospectively assessed efficacy and safety of linezolid, compared with a dose-optimized vancomycin regimen, for treatment of MRSA nosocomial pneumonia.
METHODS: This was a prospective, double-blind, controlled, multicenter trial involving hospitalized adult patients with hospital-acquired or healthcare-associated MRSA pneumonia. Patients were randomized to receive intravenous linezolid (600 mg every 12 hours) or vancomycin (15 mg/kg every 12 hours) for 7-14 days. Vancomycin dose was adjusted on the basis of trough levels. The primary end point was clinical outcome at end of study (EOS) in evaluable per-protocol (PP) patients. Prespecified secondary end points included response in the modified intent-to-treat (mITT) population at end of treatment (EOT) and EOS and microbiologic response in the PP and mITT populations at EOT and EOS. Survival and safety were also evaluated.
RESULTS: Of 1184 patients treated, 448 (linezolid, n = 224; vancomycin, n = 224) were included in the mITT and 348 (linezolid, n = 172; vancomycin, n = 176) in the PP population. In the PP population, 95 (57.6%) of 165 linezolid-treated patients and 81 (46.6%) of 174 vancomycin-treated patients achieved clinical success at EOS (95% confidence interval for difference, 0.5%-21.6%; P = .042). All-cause 60-day mortality was similar (linezolid, 15.7%; vancomycin, 17.0%), as was incidence of adverse events. Nephrotoxicity occurred more frequently with vancomycin (18.2%; linezolid, 8.4%).
CONCLUSIONS: For the treatment of MRSA nosocomial pneumonia, clinical response at EOS in the PP population was significantly higher with linezolid than with vancomycin, although 60-day mortality was similar.

PMID 22247123  Clin Infect Dis. 2012 Mar 1;54(5):621-9. doi: 10.1093/c・・・
著者: Andre C Kalil, Michael Klompas, Gleb Haynatzki, Mark E Rupp
雑誌名: BMJ Open. 2013 Oct 14;3(10):e003912. doi: 10.1136/bmjopen-2013-003912. Epub 2013 Oct 14.
Abstract/Text OBJECTIVE: Hospital-acquired pneumonia remains the most lethal and expensive nosocomial infection worldwide. Optimal therapy remains controversial. We aimed to compare mortality and clinical response outcomes in patients treated with either linezolid or vancomycin.
DESIGN: Systematic review and meta-analysis.
DATA SOURCES: PubMed, EMBASE, Cochrane Library, American College of Physicians Journal Club, Evidence-based Medicine BMJ and abstracts from infectious diseases and critical care meetings were searched through April 2013.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES: All randomised clinical trials comparing linezolid to vancomycin for hospital-acquired pneumonia.
DATA EXTRACTION: Preferred reporting items for systematic reviews and meta-analyses guidelines were followed. One author extracted the data and two authors rechecked and verified all data.
RESULTS: Nine randomised trials with a total of 4026 patients were included. The adjusted absolute mortality risk difference (RD) between linezolid and vancomycin was 0.01% (95% CI -2.1% to 2.1%; p=0.992; I(2)=13.5%. The adjusted absolute clinical response difference was 0.9% (95% CI -1.2% to 3.1%; p=0.409; I(2)=0%. The risk of both microbiological (RD=5.6%, 95% CI -2.2% to 13.3%; p=0.159; I(2)=0%) and methicillin-resistant Staphylococcus aureus (RD=6.4%, 95% CI -4.1% to 16.9%; p=0.230; I(2)=0%) eradication were not different between linezolid and vancomycin. Gastrointestinal side effects were more frequent with linezolid (RD=0.8% (95% CI 0% to 1.5%; p=0.05), but no differences were found with renal failure, thrombocytopenia and drug discontinuation due to adverse events. Our sample size provided 99.9% statistical power to detect differences between drugs regarding clinical response and mortality.
CONCLUSIONS: Linezolid and vancomycin have similar efficacy and safety profiles. The high statistical power and the near-zero efficacy difference between both antibiotics demonstrates that no drug is superior for the treatment of hospital-acquired pneumonia.

PMID 24127058  BMJ Open. 2013 Oct 14;3(10):e003912. doi: 10.1136/bmjop・・・
著者: Nihal Piskin, Hande Aydemir, Nefise Oztoprak, Deniz Akduman, Fusun Comert, Furuzan Kokturk, Guven Celebi
雑誌名: BMC Infect Dis. 2012 Oct 24;12:268. doi: 10.1186/1471-2334-12-268. Epub 2012 Oct 24.
Abstract/Text BACKGROUND: Initial antimicrobial therapy (AB) is an important determinant of clinical outcome in patients with severe infections as pneumonia, however well-conducted studies regarding prognostic impact of inadequate initial AB in patients who are not undergoing mechanical ventilation (MV) are lacking. In this study we aimed to identify the risk factors for inadequate initial AB and to determine its subsequent impact on outcomes in both ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP).
METHODS: We retrospectively studied the accuracy of initial AB in patients with pneumonia in a university hospital in Turkey. A total of 218 patients with HAP and 130 patients with VAP were included. For each patient clinical, radiological and microbiological data were collected. Stepwise multivariate logistic regression analysis was used for risk factor analysis. Survival analysis was performed by using Kaplan-Meier method with Log-rank test.
RESULTS: Sixty six percent of patients in VAP group and 41.3% of patients in HAP group received inadequate initial AB. Multiple logistic regression analysis revealed that the risk factors for inadequate initial AB in HAP patients were; late-onset HAP (OR = 2.35 (95% CI, 1.05-5.22; p = 0.037) and APACHE II score at onset of HAP (OR = 1.06 (95% CI, 1.01-1.12); p = 0.018). In VAP patients; antibiotic usage in the previous three months (OR = 3.16 (95% CI, 1.27-7.81); p = 0.013) and admission to a surgical unit (OR = 2.9 (95% CI, 1.17-7.19); p = 0.022) were found to be independent risk factors for inadequate initial AB. No statistically significant difference in crude hospital mortality and 28-day mortality was observed between the treatment groups in both VAP and HAP. However we showed a significant increase in length of hospital stay, duration of mechanical ventilation and a prolonged clinical resolution in the inadequate AB group in both VAP and HAP.
CONCLUSION: Our data suggests that the risk factors for inadequate initial AB are indirectly associated with the acquisition of resistant bacteria for both VAP and HAP. Although we could not find a positive correlation between adequate initial AB and survival; empirical AB with a broad spectrum should be initiated promptly to improve secondary outcomes.

PMID 23095664  BMC Infect Dis. 2012 Oct 24;12:268. doi: 10.1186/1471-2・・・
著者: Yan Wang, Yamin Zou, Jiao Xie, Taotao Wang, Xiaowei Zheng, Hairong He, Weihua Dong, Jianfeng Xing, Yalin Dong
雑誌名: Eur J Clin Pharmacol. 2015 Jan;71(1):107-15. doi: 10.1007/s00228-014-1775-x. Epub 2014 Oct 30.
Abstract/Text PURPOSE: The optimal therapy involving linezolid or vancomycin for suspected methicillin-resistant Staphylococcus aureus (MRSA) nosocomial pneumonia (NP) remains controversial. This study compared the efficacy and safety of linezolid and vancomycin therapies in patients with NP.
METHODS: A systematic review of randomized controlled trials with meta-analyses performed by searching PubMed, EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials. We screened for relevant randomized controlled studies in which patients with NP were enrolled and linezolid and vancomycin therapies were compared.
RESULTS: Nine trials involving 2618 pneumonia patients were reviewed. Linezolid was not found to be superior to vancomycin for clinical cure when categories of pathogen were not considered and in a subgroup of NP patients with MRSA infection [relative risk (RR)=1.16, 95 % confidence interval (CI)=0.95-1.43, P=0.15]. Compared with vancomycin, linezolid has no difference in the overall microbiological eradication rate (RR=1.12, 95 % CI=0.96-1.30, P=0.15) and specific MRSA eradication rate (RR=1.16, 95 % CI=0.93-1.45, P=0.19) in NP patients. In addition, nephrotoxicity was more frequent with vancomycin (RR=0.50, 95 % CI=0.31-0.81, P=0.005), but no differences between the treatments were found for all-cause mortality, thrombocytopenia, gastrointestinal effects, and drug discontinuation due to adverse events.
CONCLUSION: These results suggest that linezolid is not superior to vancomycin with respect to both clinical and microbiological cure rates in patients with MRSA NP.

PMID 25355172  Eur J Clin Pharmacol. 2015 Jan;71(1):107-15. doi: 10.10・・・
著者: Soumitra R Eachempati, Lynn J Hydo, Jian Shou, Philip S Barie
雑誌名: J Trauma. 2009 May;66(5):1343-8. doi: 10.1097/TA.0b013e31819dca4e.
Abstract/Text BACKGROUND: Ventilator-associated pneumonia (VAP) is a leading cause of mortality in critically ill patients. Although previous studies have shown that de-escalation therapy (DT) of antibiotics may decrease costs and the development of resistant pathogens, minimal data have shown its effect in surgical patients or in any patients with septic shock. We hypothesized that DT for VAP was not associated with an increased rate of recurrent pneumonia (RP) or mortality in a high acuity cohort of critically ill surgical patients.
METHODS: All surgical intensive care unit (SICU) patients from January 2005 to May 2007 with VAP diagnosed by quantitative bronchoalveolar lavage with a positive threshold of 10,000 CFU/mL were identified. Data collected included age, gender, Acute Physiologic and Chronic Health Evaluation Score III (A3), type of bacterial or other pathogen, antibiotics used for initial and final therapy, mortality, RP, and appropriateness of initial therapy (AIT). Patients were designated as receiving AIT, DT, or escalation of antibiotic therapy based on microbiology for their VAP.
RESULTS: One hundred thirty-eight of 1,596 SICU patients developed VAP during the study period (8.7%). For VAP patients, the mean Acute Physiologic and Chronic Health Evaluation III score was 82.7 points with a mean age of 63.8 years. The RP rate was 30% and did not differ between patients receiving DT (27.3%) and those who did not receive DT (35.1%). Overall mortality was 37% (55% predicted by A3 norms) and did not differ between those receiving DT (33.8%) or not (42.1%). The most common pathogens for primary VAP were methicillin-resistant Staphylococcus aureus (14%), Escherichia coli (11%), and Pseudomonas aeruginosa (9%) whereas P. aeruginosa was the most common pathogen in RP. The AIT for all VAP was 93%. De-escalation of therapy occurred in 55% of patients with AIT whereas 8% of VAP patients required escalation of antibiotic therapy. The most commonly used initial antibiotic choice was vancomycin/piperacillin-tazobactam (16%) and the final choice was piperacillin-tazobactam (20%). Logistic regression demonstrated no specific parameter correlated with development of RP. Higher A3 (Odds ratio, 1.03; 95% confidence interval, 1.01-1.05) was associated with mortality whereas lack of RP (odds ratio, 0.31; 95% confidence interval, 0.12-0.80), and AIT reduced mortality (odds ratio, 0.024; 95% confidence interval, 0.007-0.221). Age, gender, individual pathogen, individual antibiotic regimen, and the use of DT had no effect on mortality.
CONCLUSION: De-escalation therapy did not lead to RP or increased mortality in critically ill surgical patients with VAP. De-escalation therapy was also shown to be safe in patients with septic shock. Because of its acknowledged benefits and lack of demonstrable risks, de-escalation therapy should be used whenever possible in critically ill patients with VAP.

PMID 19430237  J Trauma. 2009 May;66(5):1343-8. doi: 10.1097/TA.0b013e・・・
著者: Mi Kyong Joung, Jeong-a Lee, Soo-Youn Moon, Hae Suk Cheong, Eun-Jeong Joo, Young-Eun Ha, Kyung Mok Sohn, Seung Min Chung, Gee Young Suh, Doo Ryeon Chung, Jae-Hoon Song, Kyong Ran Peck
雑誌名: Crit Care. 2011;15(2):R79. doi: 10.1186/cc10072. Epub 2011 Mar 2.
Abstract/Text INTRODUCTION: De-escalation therapy is a strategy currently used for the management of nosocomial pneumonia. In this study, we evaluated clinical outcomes and risk factors related to de-escalation therapy in patients with intensive care unit (ICU)-acquired pneumonia.
METHODS: This was a retrospective observational cohort study of ICU patients who developed pneumonia more than 48 hours after admission to the ICU at Samsung Medical Center from September 2004 to December 2007.
RESULTS: The 137 patients comprised 44 (32.1%) who received de-escalation therapy and 93 in the non-de-escalation group. The de-escalation group showed a lower pneumonia-related mortality rate than the non-de-escalation group by day 14 (2.3% vs. 10.8%, respectively; P = 0.08) and by day 30 (2.3% vs. 14%, respectively; P = 0.03) after the diagnosis of pneumonia. The variables independently associated with ICU-acquired pneumonia-related mortality included the Acute Physiology and Chronic Health Evaluation II (APACHE II) score and the modified Clinical Pulmonary Infection Score (CPIS) after 5 days with pneumonia. The non-de-escalation group had significantly higher APACHE II score and modified CPIS after 5 days with ICU-acquired pneumonia compared to the de-escalation group. Among all patients, 20.4% (28 of 137) had negative cultures for pathogens, and 42.9% (12 of 28) received de-escalation therapy. The latter 12 patients received de-escalation therapy and survived 30 days after the diagnosis of pneumonia.
CONCLUSIONS: Patients in the de-escalation group showed a significantly lower mortality rate compared to patients in the non-de-escalation group. De-escalation therapy can be safely provided to patients with ICU-acquired pneumonia if they are clinically stable by day 5, even in those whose respiratory specimen cultures yield no specific pathogens.

PMID 21366903  Crit Care. 2011;15(2):R79. doi: 10.1186/cc10072. Epub 2・・・
著者: J A Ramirez, J Bordon
雑誌名: Arch Intern Med. 2001 Mar 26;161(6):848-50.
Abstract/Text BACKGROUND: The identification of Streptococcus pneumoniae bacteremia in hospitalized patients with community-acquired pneumonia is considered by some investigators to be an exclusion criterion for early switch from intravenous to oral therapy.
OBJECTIVE: To determine whether the switch from intravenous to oral therapy in such patients, once the bx;1patient reaches clinical stability, is associated with poor clinical outcome.
METHODS: The medical records of 400 patients with community-acquired pneumonia hospitalized at the Veterans Affairs Medical Center of Louisville (Louisville, Ky) were reviewed to identify patients with bacteremic S pneumoniae. Four criteria were used to define when a patient reached clinical stability and should be considered a candidate for switch therapy: (1) cough and shortness of breath are improving, (2) patient is afebrile for at least 8 hours, (3) white blood cell count is normalizing, and (4) oral intake and gastrointestinal tract absorption are adequate.
RESULTS: A total of 36 bacteremic patients were identified. No clinical failures occurred in 18 patients who reached clinical stability and were switched to oral therapy or in 7 patients who reached clinical stability and continued intravenous therapy. Clinical failures (5 deaths) occurred in the group of 11 patients who did not reach clinical stability.
CONCLUSION: Once a hospitalized patient with community-acquired pneumonia reaches clinical stability, it is safe to switch from intravenous to oral antibiotics even if bacteremia caused by S pneumoniae was initially documented.

PMID 11268227  Arch Intern Med. 2001 Mar 26;161(6):848-50.
著者: Jean Chastre, Michel Wolff, Jean-Yves Fagon, Sylvie Chevret, Franck Thomas, Delphine Wermert, Eva Clementi, Jesus Gonzalez, Dominique Jusserand, Pierre Asfar, Dominique Perrin, Fabienne Fieux, Sylvie Aubas, PneumA Trial Group
雑誌名: JAMA. 2003 Nov 19;290(19):2588-98. doi: 10.1001/jama.290.19.2588.
Abstract/Text CONTEXT: The optimal duration of antimicrobial treatment for ventilator-associated pneumonia (VAP) is unknown. Shortening the length of treatment may help to contain the emergence of multiresistant bacteria in the intensive care unit (ICU).
OBJECTIVE: To determine whether 8 days is as effective as 15 days of antibiotic treatment of patients with microbiologically proven VAP.
DESIGN, SETTING, AND PARTICIPANTS: Prospective, randomized, double-blind (until day 8) clinical trial conducted in 51 French ICUs. A total of 401 patients diagnosed as having developed VAP by quantitative culture results of bronchoscopic specimens and who had received initial appropriate empirical antimicrobial therapy were enrolled between May 1999 and June 2002.
INTERVENTION: A total of 197 patients were randomly assigned to receive 8 days and 204 to receive 15 days of therapy with an antibiotic regimen selected by the treating physician.
MAIN OUTCOME MEASURES: Primary outcome measures-death from any cause, microbiologically documented pulmonary infection recurrence, and antibiotic-free days-were assessed 28 days after VAP onset and analyzed on an intent-to-treat basis.
RESULTS: Compared with patients treated for 15 days, those treated for 8 days had neither excess mortality (18.8% vs 17.2%; difference, 1.6%; 90% confidence interval [CI], -3.7% to 6.9%) nor more recurrent infections (28.9% vs 26.0%; difference, 2.9%; 90% CI, -3.2% to 9.1%), but they had more mean (SD) antibiotic-free days (13.1 [7.4] vs 8.7 [5.2] days, P<.001). The number of mechanical ventilation-free days, the number of organ failure-free days, the length of ICU stay, and mortality rates on day 60 for the 2 groups did not differ. Although patients with VAP caused by nonfermenting gram-negative bacilli, including Pseudomonas aeruginosa, did not have more unfavorable outcomes when antimicrobial therapy lasted only 8 days, they did have a higher pulmonary infection-recurrence rate compared with those receiving 15 days of treatment (40.6% vs 25.4%; difference, 15.2%, 90% CI, 3.9%-26.6%). Among patients who developed recurrent infections, multiresistant pathogens emerged less frequently in those who had received 8 days of antibiotics (42.1% vs 62.0% of pulmonary recurrences, P =.04).
CONCLUSIONS: Among patients who had received appropriate initial empirical therapy, with the possible exception of those developing nonfermenting gram-negative bacillus infections, comparable clinical effectiveness against VAP was obtained with the 8- and 15-day treatment regimens. The 8-day group had less antibiotic use.

PMID 14625336  JAMA. 2003 Nov 19;290(19):2588-98. doi: 10.1001/jama.29・・・
著者: Anke H W Bruns, Jan Jelrik Oosterheert, Mathias Prokop, Jan-Willem J Lammers, Eelko Hak, Andy I M Hoepelman
雑誌名: Clin Infect Dis. 2007 Oct 15;45(8):983-91. doi: 10.1086/521893. Epub 2007 Sep 12.
Abstract/Text BACKGROUND: Timing of follow-up chest radiographs for patients with severe community-acquired pneumonia (CAP) is difficult, because little is known about the time to resolution of chest radiograph abnormalities and its correlation with clinical findings. To provide recommendations for short-term, in-hospital chest radiograph follow-up, we studied the rate of resolution of chest radiograph abnormalities in relation to clinical cure, evaluated predictors for delayed resolution, and determined the influence of deterioration of radiographic findings during follow-up on prognosis.
METHODS: A total of 288 patients who were hospitalized because of severe CAP were followed up for 28 days in a prospective multicenter study. Clinical data and scores for clinical improvement at day 7 and clinical cure at day 28 were obtained. Chest radiographs were obtained at hospital admission and at days 7 and 28. Resolution and deterioration of chest radiograph findings were determined.
RESULTS: At day 7, 57 (25%) of the patients had resolution of chest radiograph abnormalities, whereas 127 (56%) had clinical improvement (mean difference, 31%; 95% confidence interval, 25%-37%). At day 28, 103 (53%) of the patients had resolution of chest radiograph abnormalities, and 152 (78%) had clinical cure (mean difference, 25%; 95% confidence interval, 19%-31%). Delayed resolution of radiograph abnormalities was independently associated with multilobar disease (odds ratio, 2.87; P < or = .01); dullness to percussion at physical examination (odds ratio, 6.94; P < or = .01); high C-reactive protein level, defined as >200 mg/L (odds ratio, 4.24; P < or = .001); and high respiratory rate at admission, defined as >25 breaths/min (odds ratio, 2.42; P < or = .03). There were no significant differences in outcome at day 28 between patients with and patients without deterioration of chest radiograph findings during the follow-up period (P > .09).
CONCLUSIONS: Routine short-term follow-up chest radiographs (obtained <28 days after hospital admission) of hospitalized patients with severe CAP seem to provide no additional clinical value.

PMID 17879912  Clin Infect Dis. 2007 Oct 15;45(8):983-91. doi: 10.1086・・・
著者: Sabine C A Meijvis, Hans Hardeman, Hilde H F Remmelts, Rik Heijligenberg, Ger T Rijkers, Heleen van Velzen-Blad, G Paul Voorn, Ewoudt M W van de Garde, Henrik Endeman, Jan C Grutters, Willem Jan W Bos, Douwe H Biesma
雑誌名: Lancet. 2011 Jun 11;377(9782):2023-30. doi: 10.1016/S0140-6736(11)60607-7. Epub 2011 Jun 1.
Abstract/Text BACKGROUND: Whether addition of corticosteroids to antibiotic treatment benefits patients with community-acquired pneumonia who are not in intensive care units is unclear. We aimed to assess effect of addition of dexamethasone on length of stay in this group, which might result in earlier resolution of pneumonia through dampening of systemic inflammation.
METHODS: In our double-blind, placebo-controlled trial, we randomly assigned adults aged 18 years or older with confirmed community-acquired pneumonia who presented to emergency departments of two teaching hospitals in the Netherlands to receive intravenous dexamethasone (5 mg once a day) or placebo for 4 days from admission. Patients were ineligible if they were immunocompromised, needed immediate transfer to an intensive-care unit, or were already receiving corticosteroids or immunosuppressive drugs. We randomly allocated patients on a one-to-one basis to treatment groups with a computerised randomisation allocation sequence in blocks of 20. The primary outcome was length of hospital stay in all enrolled patients. This study is registered with ClinicalTrials.gov, number NCT00471640.
FINDINGS: Between November, 2007, and September, 2010, we enrolled 304 patients and randomly allocated 153 to the placebo group and 151 to the dexamethasone group. 143 (47%) of 304 enrolled patients had pneumonia of pneumonia severity index class 4-5 (79 [52%] patients in the dexamethasone group and 64 [42%] controls). Median length of stay was 6·5 days (IQR 5·0-9·0) in the dexamethasone group compared with 7·5 days (5·3-11·5) in the placebo group (95% CI of difference in medians 0-2 days; p=0·0480). In-hospital mortality and severe adverse events were infrequent and rates did not differ between groups, although 67 (44%) of 151 patients in the dexamethasone group had hyperglycaemia compared with 35 (23%) of 153 controls (p<0·0001).
INTERPRETATION: Dexamethasone can reduce length of hospital stay when added to antibiotic treatment in non-immunocompromised patients with community-acquired pneumonia.
FUNDING: None.

Copyright © 2011 Elsevier Ltd. All rights reserved.
PMID 21636122  Lancet. 2011 Jun 11;377(9782):2023-30. doi: 10.1016/S01・・・
著者: Shane Patman, Sue Jenkins, Kathy Stiller
雑誌名: Intensive Care Med. 2009 Feb;35(2):258-65. doi: 10.1007/s00134-008-1278-2. Epub 2008 Sep 24.
Abstract/Text OBJECTIVE: To investigate the effect of respiratory physiotherapy on the prevention and treatment of ventilator-associated pneumonia (VAP) for adults in an intensive care unit (ICU) with an acquired brain injury (ABI).
DESIGN AND SETTING: Two-part, prospective, randomised controlled trial.
PATIENTS: A total of 144 subjects with ABI admitted with a Glasgow Coma Scale 24 h; 33 subjects were subsequently diagnosed with VAP.
INTERVENTION: Respiratory physiotherapy comprised six treatments (positioning, manual hyperinflation and suctioning) in each 24-h period whilst on MV. The Control Group received standard medical/nursing care but no respiratory physiotherapy.
MEASUREMENTS AND RESULTS: There were no significant differences between groups for incidence of VAP, duration of MV, length of ICU stay or clinical variables such as requirement for re-ventilation.
CONCLUSIONS: In adults with ABI, regular respiratory physiotherapy in addition to routine medical/nursing care does not appear to prevent VAP, reduce length of MV or ICU stay. Due to small numbers, it is not possible to draw any conclusions as to whether or not respiratory physiotherapy hastens recovery from VAP.

PMID 18813910  Intensive Care Med. 2009 Feb;35(2):258-65. doi: 10.1007・・・
著者: C Paludo, L Zhang, C S Lincho, D V Lemos, G G Real, J A Bergamin
雑誌名: Thorax. 2008 Sep;63(9):791-4. doi: 10.1136/thx.2007.088195. Epub 2008 Feb 14.
Abstract/Text BACKGROUND: The indication for chest physical therapy as an adjunct to the treatment of children hospitalised with acute pneumonia remains controversial and there is a lack of robust scientific evidence for the effectiveness of this modality in these patients.
METHODS: A randomised controlled trial was conducted in two tertiary hospitals in southern Brazil. Children aged 29 days to 12 years hospitalised with pneumonia between February and October 2006 were recruited; 51 were randomly allocated to the intervention group (chest physical therapy plus standard treatment for pneumonia) and 47 to the control group (standard treatment for pneumonia alone). The primary outcome was time to clinical resolution. The secondary outcomes were length of stay in hospital and duration of respiratory symptoms and signs.
RESULTS: There were no significant differences in terms of median time to clinical resolution (4.0 vs 4.0 days, p = 0.84) and median length of hospital stay (6.0 vs 6.0 days, p = 0.76) between the intervention and control groups. The intervention group had a longer median duration of coughing (5.0 vs 4.0 days, p = 0.04) and of rhonchi on lung auscultation (2.0 vs 0.5 days, p = 0.03) than the control group.
CONCLUSIONS: Chest physical therapy as an adjunct to standard treatment does not hasten clinical resolution of children hospitalised with acute pneumonia and may prolong duration of coughing and rhonchi.

PMID 18276723  Thorax. 2008 Sep;63(9):791-4. doi: 10.1136/thx.2007.088・・・

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