Doripenem in the Treatment of Complicated Intra-Abdominal Infections
The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.
Bacterial Infections and Mycoses
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections|
- The clinical response measured at late follow-up visit.
- The clinical response at early follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) conducted throughout the study.
|Study Start Date:||March 2004|
|Study Completion Date:||March 2006|
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of doripenem versus comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. Doripenem or comparator is administered. The primary endpoint is the clinical response measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|