Telavancin for hospital-acquired pneumonia: clinical response and 28-day survival.

Abstract

U.S. Food and Drug Administration draft guidance for future antibiotic clinical trials of bacterial nosocomial pneumonia recommends the use of diagnostic criteria according to American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) guidelines and the use of a primary endpoint of 28-day all-cause mortality. The effect of applying these guidelines on outcomes of phase III nosocomial pneumonia studies of telavancin was evaluated in a post hoc analysis. ATS/IDSA criteria were applied in a blind 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). The exploratory endpoint of 28-day survival was evaluated for the ATS/IDSA-AT group. Noninferiority of telavancin versus vancomycin was demonstrated, with similar cure rates in the ATS/IDSA-AT (59% versus 59%) and ATS/IDSA-CE (83% versus 80%) groups. Cure rates favored telavancin in ATS/IDSA-CE patients where Staphylococcus aureus was the sole pathogen (86% versus 75%). Overall, 28-day survival rates were similar in the telavancin (76%) and vancomycin (77%) groups but lower in telavancin-treated patients with preexisting moderate-to-severe renal impairment (creatinine clearance [CLCR] of <50 ml/min). Telavancin should be administered to patients with moderate-to-severe renal impairment only if treatment benefit outweighs the risk or if no suitable alternatives are available.

• Authors: G Ralph Corey, Marin H Kollef, Andrew F Shorr, Ethan Rubinstein, Martin E Stryjewski, Alan Hopkins, Steven L Barriere
• Journal: Antimicrobial agents and chemotherapy (Antimicrob Agents Chemother) Vol. 58 Issue 4 Pg. 2030-7 ( 2014) ISSN: 1098-6596 [Electronic] United States
• PMID: 24419353 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Aminoglycosides
• Anti-Bacterial Agents
• Lipoglycopeptides
• Vancomycin
• telavancin

Topics

• Adult
• Aged
• Aged, 80 and over
• Aminoglycosides (pharmacology, therapeutic use)
• Anti-Bacterial Agents (pharmacology, therapeutic use)
• Cross Infection
• Female
• Humans
• Lipoglycopeptides
• Male
• Middle Aged
• Pneumonia (drug therapy, microbiology, mortality)
• Staphylococcus aureus (drug effects)
• United States
• Vancomycin (pharmacology, therapeutic use)