title: Ertapenem monotherapy versus combination therapy with ceftriaxone plus metronidazole for treatment of complicated intra-abdominal infections in adults.
abstract: The efficacy and safety of intravenous (IV) ertapenem, 1 and 1.5 g once a day, for treatment of adults with complicated intra-abdominal infection were compared with those of IV ceftriaxone 2 g once a day plus IV metronidazole 500 mg every 8 h. After at least 3 days of IV therapy and satisfactory clinical response, patients could be switched to oral ciprofloxacin plus metronidazole. Fifty-nine patients were randomized to receive ertapenem 1 g and 51 to receive ertapenem 1.5 g; 55 patients were randomized to each comparator group. At the test of cure, 4-6 weeks post therapy, in the 1 g cohort, 84% (26/31) of patients treated with ertapenem and 85% (35/41) with comparator therapy had a favourable clinical and microbiological assessment. Success rates in the 1.5 g cohort were 83% (22/29) and 77% (24/31) in the ertapenem and comparator groups, respectively. Drug-related adverse events were generally similar in both treatment groups. Ertapenem 1 or 1.5 g once a day followed by optional oral therapy appeared similar to combined therapy with ceftriaxone plus metronidazole with the same optional oral switch for treatment of complicated intra-abdominal infections in adults. Although not compared directly in a randomized fashion, the efficacy and safety profiles of ertapenem 1 and 1.5 g appeared comparable. Ertapenem was generally well tolerated and had an overall safety profile similar to ceftriaxone plus metronidazole.
authors.affiliation: LAC-USC Medical Center, Los Angeles, CA, USA.
authors.forename: Albert E
authors.initials: AE
authors.lastname: Yellin
authors.forename: James M
authors.initials: JM
authors.lastname: Hassett
authors.forename: Alvaro
authors.initials: A
authors.lastname: Fernandez
authors.forename: James
authors.initials: J
authors.lastname: Geib
authors.forename: Ben
authors.initials: B
authors.lastname: Adeyi
authors.forename: Gail L
authors.initials: GL
authors.lastname: Woods
authors.forename: Hedy
authors.initials: H
authors.lastname: Teppler
mesh_terms: D000005:Abdomen / Q000382:microbiology*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002443:Ceftriaxone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D000077727:Ertapenem; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D007769:Lactams; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D047090:beta-Lactams
chemical_list: D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D007769:Lactams; D047090:beta-Lactams; D008795:Metronidazole; D002443:Ceftriaxone; D000077727:Ertapenem