Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)
Phase 3
Completed
- Conditions
- Complicated Intra-Abdominal Infections
- Registration Number
- NCT00389987
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with respect to the clinical response in baseline microbiologically evaluable patients; and to evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.
- Detailed Description
Original label approved November 2001
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Male or female patients (greater or equal to 18 years of age)
- Intraoperative/Postoperative Enrollment: Upon visual confirmation of an intra-abdominal infection.
- Preoperative Enrollment: Patients may be enrolled preoperatively if they meet certain criteria
Exclusion Criteria
- Failure to meet all inclusion criteria.
- Patients who are considered unlikely to survive the 6-8 week study period.
- Pregnant or nursing women, or fertile women not practicing adequate methods of contraception.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment. 2-weeks post-treatment
- Secondary Outcome Measures
Name Time Method In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 4-6 weeks post-treatment Late Follow-up Assessment. 4-6 Weeks post-treatment