title: Ertapenem versus cefepime for initial empirical treatment of pneumonia acquired in skilled-care facilities or in hospitals outside the intensive care unit.
abstract: 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 (<or=15 vs >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.
authors.affiliation: Municipal Hospital #7, Moscow, and Smolensk State Medical Academy, Russia.
authors.forename: S V
authors.initials: SV
authors.lastname: Yakovlev
authors.forename: L S
authors.initials: LS
authors.lastname: Stratchounski
authors.forename: G L
authors.initials: GL
authors.lastname: Woods
authors.forename: B
authors.initials: B
authors.lastname: Adeyi
authors.forename: K A
authors.initials: KA
authors.lastname: McCarroll
authors.forename: J A
authors.initials: JA
authors.lastname: Ginanni
authors.forename: I R
authors.initials: IR
authors.lastname: Friedland
authors.forename: C A
authors.initials: CA
authors.lastname: Wood
authors.forename: M J
authors.initials: MJ
authors.lastname: DiNubile
mesh_terms: D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000077723:Cefepime; D002511:Cephalosporins / Q000008:administration & dosage* / Q000009:adverse effects; D003428:Cross Infection / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004755:Enterobacteriaceae / Q000302:isolation & purification; D004756:Enterobacteriaceae Infections / Q000188:drug therapy / Q000382:microbiology; D000077727:Ertapenem; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D011446:Prospective Studies; D012866:Skilled Nursing Facilities; D047090:beta-Lactams / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D047090:beta-Lactams; D000077723:Cefepime; D000077727:Ertapenem