Overview

Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)

Status:
Completed
Trial end date:
2004-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Ertapenem
Penicillanic Acid
Piperacillin
Piperacillin, tazobactam drug combination
Tazobactam
Criteria
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.