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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Complicated Intra-Abdominal Infections

Treatments

Drug: MK0826, /Duration of Treatment : 8 Weeks

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00389987

0826-037

2006_538

Details and patient eligibility

About

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.

Full description

Original label approved November 2001

Sex

All

Ages

18+ years old

Volunteers

No 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.