Ertapenem versus cefepime for initial empirical treatment of pneumonia acquired in skilled- care facilities or in hospitals outside the intensive care unit

• Published in: European journal of clinical microbiology & infectious diseases 2006-10, Vol.25 (10), p.633-641
• Main Authors: YAKOVLEV, S. V, STRATCHOUNSKI, L. S, WOODS, G. L, ADEYI, B, MCCARROLL, K. A, GINANNI, J. A, FRIEDLAND, I. R, WOOD, C. A, DINUBILE, M. J
• Format: Article
• Language: English
• Subjects: Aged; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - adverse effects; beta-Lactams - administration & dosage; beta-Lactams - adverse effects; Cephalosporins - administration & dosage; Cephalosporins - adverse effects; Confidence intervals; Cross Infection - drug therapy; Cross Infection - microbiology; Double-Blind Method; Drug Administration Schedule; Drug therapy; Enterobacteriaceae - isolation & purification; Enterobacteriaceae Infections - drug therapy; Enterobacteriaceae Infections - microbiology; Female; Humans; Intensive Care Units; Male; Middle Aged; Pathogens; Pneumonia, Bacterial - drug therapy; Pneumonia, Bacterial - microbiology; Prospective Studies; Skilled Nursing Facilities; Staphylococcus infections; Streptococcus infections; Ventilation
• ISSN: 0934-9723; 1435-4373
• DOI: 10.1007/s10096-006-0193-0

The study presented here compared the efficacy and safety of ertapenem and cefepime as initial treatment for adults with pneumonia acquired in skilled-care facilities or in hospital environments outside the intensive care unit (ICU). Non-ventilated patients developing pneumonia in hospital environments outside the ICU, in nursing homes, or in other skilled-care facilities were enrolled in this double-blind non-inferiority study, stratified by APACHE II score (15) and randomized (1:1) to receive cefepime (2 g every 12 h with optional metronidazole 500 mg every 12 h) or ertapenem (1 g daily). After 3 days of parenteral therapy, participants demonstrating clinical improvement could be switched to oral ciprofloxacin or another appropriate oral agent. Probable pathogens were identified in 162 (53.5%) of the 303 randomized participants. The most common pathogens were Enterobacteriaceae, Streptococcus pneumoniae, and Staphylococcus aureus, isolated from 59 (19.5%), 39 (12.9%), and 35 (11.6%) participants, respectively. At the test-of-cure assessment 7-14 days after completion of all study therapy, pneumonia had resolved or substantially improved in 89 (87.3%) of 102 clinically evaluable ertapenem recipients and 80 (86%) of 93 clinically evaluable cefepime recipients (95% confidence interval for the difference, -9.4 to 11.8%), fulfilling pre-specified criteria for statistical non-inferiority. The frequency and severity of drug-related adverse events were generally similar in both treatment groups. In this study population, ertapenem was as well-tolerated and efficacious as cefepime for the initial treatment of pneumonia acquired in skilled-care facilities or in hospital environments outside the ICU.