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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/cid/ciq031.
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