Status:
COMPLETED
Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Complicated Intra-Abdominal Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 tole...
Detailed Description
Original label approved November 2001
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
May 1 2004
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00389987
Start Date
September 1 2001
End Date
May 1 2004
Last Update
February 17 2017
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