Safety and tolerability of ertapenem versus ceftriaxone in a double-blind study performed in children with complicated urinary tract infection, community-acquired pneumonia or skin and soft-tissue infection

Int J Antimicrob Agents. 2009 Feb;33(2):163-7. doi: 10.1016/j.ijantimicag.2008.08.005. Epub 2008 Oct 21.


The carbapenem antibiotic ertapenem has been shown to be safe, well tolerated and effective in treating adults with complicated urinary tract infection, skin and soft-tissue infection and community-acquired pneumonia. In this study, we evaluated ertapenem for treating these infections in children in a randomised, double-blind, active-controlled clinical trial. The primary outcome was the incidence of clinical and laboratory drug-related serious adverse events (AEs). Children were randomised in a 3:1 ratio (ertapenem:ceftriaxone) stratified by index infection and age to receive ertapenem or ceftriaxone; 303 children received ertapenem and 100 children received ceftriaxone. The median duration of parenteral therapy was 4 days for both treatments. The most commonly reported drug-related clinical AEs during parenteral therapy were diarrhoea (5.9% ertapenem, 10% ceftriaxone), infusion site erythema (3% ertapenem, 2% ceftriaxone) and infusion site pain (5% ertapenem, 1% ceftriaxone). One child in each group reported a serious drug-related clinical AE. No serious drug-related laboratory AEs were reported. In children aged 3 months to 17 years, ertapenem was well tolerated and had a comparable safety profile to that of ceftriaxone.

Trial registration: NCT00451386.

Publication types

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

MeSH terms

  • Adolescent
  • Anti-Bacterial Agents / adverse effects*
  • Anti-Bacterial Agents / therapeutic use
  • Ceftriaxone / adverse effects*
  • Ceftriaxone / therapeutic use
  • Child
  • Child, Preschool
  • Community-Acquired Infections
  • Double-Blind Method
  • Ertapenem
  • Female
  • Humans
  • Infant
  • Male
  • Molecular Sequence Data
  • Pneumonia, Bacterial / drug therapy*
  • Skin Diseases, Bacterial / drug therapy*
  • Soft Tissue Infections / drug therapy*
  • Urinary Tract Infections / drug therapy*
  • beta-Lactams / adverse effects*
  • beta-Lactams / therapeutic use


  • Anti-Bacterial Agents
  • beta-Lactams
  • Ceftriaxone
  • Ertapenem

Associated data