Telavancin for Hospital-acquired Pneumonia: Clinical Response and 28-Day Survival.
Antimicrob Agents Chemother. 2014 Jan 13;
Authors: Corey GR, Kollef MH, Shorr AF, Rubinstein E, Stryjewski ME, Hopkins A, Barriere SL
United States Food and Drug Administration draft guidance for future antibiotic clinical trials of bacterial nosocomial pneumonia (NP) recommends using diagnostic criteria from the American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines, and using a primary end point of 28-day all-cause mortality. The effect of applying these guidelines on outcomes of the phase III NP studies of telavancin was evaluated in a post-hoc analysis. ATS/IDSA criteria were applied in a blinded fashion to the original all-treated (AT) group. Clinical cure rates at final follow-up were determined in the refined AT and clinically-evaluable (CE) groups (ATS/IDSA-AT and ATS/IDSA-CE, respectively). Exploratory end point of 28-day survival was evaluated in the ATS/IDSA-AT group. Non-inferiority of telavancin versus vancomycin was demonstrated, with similar cure rates in the ATS/IDSA-AT (59% versus 59%, respectively) and ATS/IDSA-CE groups (83% versus 80%, respectively). Cure rates favored telavancin in ATS/IDSA-CE patients where Staphylococcus aureus was the sole pathogen (86% versus 75%). Overall, 28-day survival was similar in the telavancin (76%) and vancomycin (77%) groups, but lower in telavancin-treated patients with pre-existing moderate-to-severe renal impairment (CLCR <50 ml/min). Telavancin should only be administered to patients with moderate-to-severe renal impairment if treatment benefit outweighs risk, or if no suitable alternatives are available.
PMID: 24419353 [PubMed - as supplied by publisher]