Clinical Trial: An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Ertapenem Sodium ( MK0826) Versus Ticarcillin/Clavulanate in the Treatment o
Brief Summary: The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.
Detailed Summary: The duration of treatment is 18 months.
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: September 21, 2004
Date Started: March 2002
Date Completion:
Last Updated: February 16, 2017
Last Verified: February 2017