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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2004-05-31

Brief Summary

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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.

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Detailed Description

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Original label approved November 2001

Conditions

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Complicated Intra-Abdominal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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MK0826, /Duration of Treatment : 8 Weeks

Intervention Type DRUG

Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks

Intervention Type DRUG

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No