title: Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial.
abstract: BACKGROUND
  This randomized, open-label, multi-center trial compared tigecycline (TGC), a broad-spectrum glycylcycline, with ceftriaxone-metronidazole (CTX/MET) for the treatment of complicated intra-abdominal infections (cIAI).
  
  
  METHODS
  Eligible subjects were randomized to receive TGC 100 mg followed by 50 mg q 12 h or CTX 2 g qd plus MET 1-2 g daily for 4-14 days. Subjects were stratified by Acute Physiology and Chronic Health Evaluation (APACHE) II score ≤10 or >10 and could not receive oral therapy. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test of cure (TOC) assessment 8-44 days after the last drug dose.
  
  
  RESULTS
  Clinical responses in the CE population were 81.8% (162/198) vs. 79.4% (150/189) for TGC and CTX/MET, respectively; a weighted estimate of the difference of 1.6 (95% confidence interval [CI] -6.4, 9.6). In the microbiologically evaluable (ME) population, microbiological eradication rates were 82.4% (98/119) for TGC vs. 79.6% (86/108) for CTX/MET: a difference of 2.7 (95% CI -7.9, 13.3). Common adverse events were nausea (21.6% TGC vs. 21.3% CTX/MET) and vomiting (17.7% TGC vs. 13.2% CTX/MET). Discontinuation rates because of adverse events were 7.8% for TGC and 6.4% for CTX/MET.
  
  
  CONCLUSIONS
  Tigecycline was effective in the treatment of cIAI and was non-inferior to CTX/MET for the treatment of cIAI in hospitalized adults. Clinical Trials Identifier: NCT00230971.
authors.affiliation: Surgical Department A, Odense University Hospital, Odense, Denmark. famqvist@dadlnet.dk
authors.forename: Niels
authors.initials: N
authors.lastname: Qvist
authors.forename: Brian
authors.initials: B
authors.lastname: Warren
authors.forename: Heidi
authors.initials: H
authors.lastname: Leister-Tebbe
authors.forename: Edward T
authors.initials: ET
authors.lastname: Zito
authors.forename: Ronald
authors.initials: R
authors.lastname: Pedersen
authors.forename: Paul C
authors.initials: PC
authors.lastname: McGovern
authors.forename: Tim
authors.initials: T
authors.lastname: Babinchak
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002443:Ceftriaxone / Q000008:administration & dosage* / Q000009:adverse effects; D004322:Drainage / Q000009:adverse effects / Q000379:methods; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D059413:Intraabdominal Infections / Q000188:drug therapy*; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use*; D008875:Middle Aged; D008911:Minocycline / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000078304:Tigecycline; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D000078304:Tigecycline; D002443:Ceftriaxone; D008911:Minocycline