The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections: analysis of pooled clinical trial data

Clin Infect Dis. 2005 Sep 1:41 Suppl 5:S354-67. doi: 10.1086/431676.

Abstract

This pooled analysis includes 2 phase 3, double-blind trials designed to evaluate the safety and efficacy of tigecycline, versus that of imipenem-cilastatin, in 1642 adults with complicated intra-abdominal infections. Patients were randomized to receive either tigecycline (initial dose of 100 mg, followed by 50 mg intravenously every 12 h) or imipenem-cilastatin (500/500 mg intravenously every 6 h) for 5-14 days. The primary end point was the clinical response at the test-of-cure visit (12-42 days after therapy) in the co-primary end point microbiologically evaluable and microbiological modified intent-to-treat populations. For the microbiologically evaluable group, clinical cure rates were 86.1% (441/512) for tigecycline, versus 86.2% (442/513) for imipenem-cilastatin (95% confidence interval for the difference, -4.5% to 4.4%; P < .0001 for noninferiority). Clinical cure rates in the microbiological modified intent-to-treat population were 80.2% (506/631) for tigecycline, versus 81.5% (514/631) for imipenem-cilastatin (95% confidence interval for the difference, -5.8% to 3.2%; P < .0001 for noninferiority). Nausea (24.4% tigecycline, 19.0% imipenem-cilastatin [P = .01]), vomiting (19.2% tigecycline, 14.3% imipenem-cilastatin [P = .008]), and diarrhea (13.8% tigecycline, 13.2% imipenem-cilastatin [P = .719]) were the most frequently reported adverse events. This pooled analysis demonstrates that tigecycline was efficacious and well tolerated in the treatment of patients with complicated intra-abdominal infections.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Bacteria / drug effects
  • Bacterial Infections / drug therapy*
  • Cilastatin / adverse effects
  • Cilastatin / therapeutic use
  • Cilastatin, Imipenem Drug Combination
  • Drug Combinations
  • Female
  • Humans
  • Imipenem / adverse effects
  • Imipenem / therapeutic use
  • Intestinal Diseases / drug therapy*
  • Intestinal Diseases / microbiology
  • Male
  • Microbial Sensitivity Tests
  • Middle Aged
  • Minocycline / adverse effects
  • Minocycline / analogs & derivatives*
  • Minocycline / therapeutic use
  • Tigecycline

Substances

  • Anti-Bacterial Agents
  • Drug Combinations
  • Cilastatin
  • Tigecycline
  • Imipenem
  • Cilastatin, Imipenem Drug Combination
  • Minocycline