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

A Prospective, Multicenter, Double-Blind With In-House Blinding, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Sodium Versus Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections in Hospitalized Adults

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00389987

Enrollment

300

Registered

2006-10-19

Start date

2001-09-30

Completion date

2004-05-31

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complicated Intra-Abdominal Infections

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

Interventions

DRUGMK0826, /Duration of Treatment : 8 Weeks

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026