Telavancin for Hospital-Acquired Pneumonia: Clinical Response and 28-Day Survival
Antimicrobial Agents and Chemotherapy April 2014 V.59 N.4 P.2030-2037
Ralph Corey, Marin H. Kollef, Andrew F. Shorr, Ethan Rubinstein, Martin E. Stryjewski, Alan Hopkins, and Steven L. Barriere
aDepartment of Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA
bPulmonary and Critical Care Division, Washington University School of Medicine, St. Louis, Missouri, USA
cPulmonary and Critical Care Medicine, Washington Hospital Center, Washington, DC, USA
dUniversity of Manitoba, Winnipeg, Manitoba, Canada
eDepartment of Medicine, Section of Infectious Diseases, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno, Buenos Aires, Argentina
fTheravance, Inc., South San Francisco, California, USA
U.S. Food and Drug Administration draft guidance for future antibiotic clinical trials of bacterial nosocomial pneumonia recommends the use of diagnostic criteria according to American Thoracic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.
Entry filed under: Antimicrobianos, Bacterias, Bacteriemias, Epidemiología, Health Care-Associated Infections, Infecciones nosocomiales, Infecciones respiratorias, Metodos diagnosticos, Resistencia bacteriana, Sepsis, Update.