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

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

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.