Doripenem in the Treatment of Complicated Intra-Abdominal Infections
Phase 3
Completed
- Conditions
- Bacterial Infections and MycosesCholecystitisAppendicitisPancreatitisPeritonitis
- Registration Number
- NCT00229060
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 483
Inclusion Criteria
- Has a requirement for surgical intervention within 24 hours of study entry
- Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections
Exclusion Criteria
- Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control
- Any rapidly-progressing disease or immediately life-threatening illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The clinical response measured at late follow-up visit.
- Secondary Outcome Measures
Name Time Method 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.