title: Moxifloxacin is non-inferior to combination therapy with ceftriaxone plus metronidazole in patients with community-origin complicated intra-abdominal infections.
abstract: Management of community-origin complicated intra-abdominal infections (cIAIs) requires surgical intervention and antimicrobial therapy. This multinational, randomised, double-blind clinical trial carried out in Asia compared the efficacy and safety of moxifloxacin monotherapy and ceftriaxone/metronidazole combination therapy in adults with confirmed or suspected cIAI. Patients received surgical intervention and either intravenous (i.v.) moxifloxacin 400 mg once daily or i.v. ceftriaxone 2 g once daily plus i.v. metronidazole 500 mg twice daily. A total of 364 patients were randomised [intent-to-treat (ITT), moxifloxacin N=180, comparator N=181; per-protocol (PP), moxifloxacin N=174, comparator N=171]. The most common cIAI diagnosis was complicated appendicitis. Moxifloxacin was non-inferior to ceftriaxone/metronidazole in terms of clinical response at test-of-cure in the PP population [clinical cure, 90.2% for moxifloxacin vs. 96.5% for ceftriaxone/metronidazole; 95% confidence interval (CI) of the difference -11.7 to -1.7] and in the ITT population (87.2% for moxifloxacin vs. 91.2% for ceftriaxone/metronidazole; 95% CI -10.7 to 1.9). Bacteriological cure rates in the microbiologically evaluable population support the clinical results (89.4% for moxifloxacin vs. 95.9% for ceftriaxone/metronidazole; 95% CI -13.3 to -0.6). The incidence of treatment-emergent adverse events was similar for both treatment groups (moxifloxacin 31.7% vs. comparator 24.3%). These results confirm previous findings that moxifloxacin plus adequate source control is an appropriate treatment of cIAI.
authors.affiliation: Division of Trauma/Critical Care, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH 45267-0558, USA. joseph.solomkin@uc.edu
authors.forename: Joseph
authors.initials: J
authors.lastname: Solomkin
authors.forename: Yu-Pei
authors.initials: YP
authors.lastname: Zhao
authors.forename: En-Ling
authors.initials: EL
authors.lastname: Ma
authors.forename: Min-Jun
authors.initials: MJ
authors.lastname: Chen
authors.forename: Barbara
authors.initials: B
authors.lastname: Hampel
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001208:Asia; D001372:Aza Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002443:Ceftriaxone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017714:Community-Acquired Infections / Q000188:drug therapy* / Q000601:surgery; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D000077266:Moxifloxacin; D010538:Peritonitis / Q000188:drug therapy* / Q000601:surgery; D011804:Quinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D008795:Metronidazole; D002443:Ceftriaxone; D000077266:Moxifloxacin