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

Merck Sharp & Dohme LLC300 enrolled

Overview

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.

Original label approved November 2001

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Complicated Intra-Abdominal Infections

Interventions

MK0826, /Duration of Treatment : 8 WeeksDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

In microbiologically evaluable patients, ertapenem will be at least as effective as piperacillin/tazobactam at the 2-weeks post-treatment Early Follow-up Assessment.

Time frame: 2-weeks post-treatment

Secondary Outcomes

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.

Time frame: 4-6 Weeks post-treatment

Data from ClinicalTrials.gov

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