title: A prospective, double-blind, multicenter, randomized trial comparing ertapenem 3 vs >or=5 days in community-acquired intraabdominal infection.
abstract: Severe secondary peritonitis is diagnosed in only 20-30% of all patients, but studies to date have persisted in using a standard fixed duration of antibiotic therapy. This prospective, double-blind, multicenter, randomized clinical study compared the clinical and bacteriological efficacy and tolerability of ertapenem (1 g/day) 3 days (group I) vs >or=5 days (group II) in 111 patients with localized peritonitis (appendicitis vs non-appendicitis) of mild to moderate severity, requiring surgical intervention. In evaluable patients, the clinical response as primary efficacy outcome were assessed at the test-of-cure 2 and 4 weeks after discontinuation of antibacterial therapy. Ninety patients were evaluable. In groups I and II, 92.9 and 89.6% of patients were cured, respectively; 95.3% in group I and 93.7% in group II showed eradication. These differences were not statistically significant. The most frequent bacteria recovered were Escherichia coli and Bacteroides fragilis. A wound infection developed in seven patients (7.7%) and an intraabdominal infection in one patient (1.1%). There was a low frequency of drug-related clinical or laboratory adverse effects in both groups. Our study demonstrated that, in patients with localized community-acquired intraabdominal infection, a 3-day course of ertapenem had the same clinical and bacteriological efficacy as a standard duration.
authors.affiliation: Department Paride Stefanini, University La Sapienza, Policlinico Umberto I Viale del Policlinico, 00161, Rome, Italy. antonio.basoli@uniroma1.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Basoli
authors.forename: Piero
authors.initials: P
authors.lastname: Chirletti
authors.forename: Ercole
authors.initials: E
authors.lastname: Cirino
authors.forename: Nicola G
authors.initials: NG
authors.lastname: D'Ovidio
authors.forename: Giovanni Battista
authors.initials: GB
authors.lastname: Doglietto
authors.forename: Domenico
authors.initials: D
authors.lastname: Giglio
authors.forename: Stefano M
authors.initials: SM
authors.lastname: Giulini
authors.forename: Alberto
authors.initials: A
authors.lastname: Malizia
authors.forename: Mario
authors.initials: M
authors.lastname: Taffurelli
authors.forename: Jelena
authors.initials: J
authors.lastname: Petrovic
authors.forename: Maurizio
authors.initials: M
authors.lastname: Ecari
mesh_terms: D018806:APACHE; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001064:Appendicitis / Q000150:complications; D017714:Community-Acquired Infections / Q000188:drug therapy / Q000382:microbiology; D004311:Double-Blind Method; D000077727:Ertapenem; D006801:Humans; D010538:Peritonitis / Q000188:drug therapy* / Q000209:etiology / Q000382:microbiology; D011446:Prospective Studies; D013530:Surgical Wound Infection / Q000453:epidemiology; D047090:beta-Lactams / Q000008:administration & dosage*
chemical_list: D000900:Anti-Bacterial Agents; D047090:beta-Lactams; D000077727:Ertapenem