title: 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abstract: U.S. Food and Drug Administration draft guidance for future antibiotic clinical trials of bacterial nosocomial pneumonia recommends the use of diagnostic criteria according to American Thoracic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.affiliation: Department of Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA.
authors.forename: G Ralph
authors.initials: GR
authors.lastname: Corey
authors.forename: Marin H
authors.initials: MH
authors.lastname: Kollef
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Shorr
authors.forename: Ethan
authors.initials: E
authors.lastname: Rubinstein
authors.forename: Martin E
authors.initials: ME
authors.lastname: Stryjewski
authors.forename: Alan
authors.initials: A
authors.lastname: Hopkins
authors.forename: Steven L
authors.initials: SL
authors.lastname: Barriere
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides / Q000494:pharmacology / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000494:pharmacology / Q000627:therapeutic use*; D003428:Cross Infection; D005260:Female; D006801:Humans; D000077427:Lipoglycopeptides; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000188:drug therapy* / Q000382:microbiology / Q000401:mortality*; D013211:Staphylococcus aureus / Q000187:drug effects; D014481:United States; D014640:Vancomycin / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000077427:Lipoglycopeptides; D014640:Vancomycin; C487637:telavancin