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

NCT00389987 Phase 3 COMPLETED

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.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	COMPLETED
Enrolment	300
Start date	2001-09
Completion	2004-05

Conditions

• Complicated Intra-Abdominal Infections

Interventions

• MK0826, /Duration of Treatment : 8 Weeks
• Comparator : piperacillin sodium (+) tazobactam sodium /Duration of Treatment : 8 Weeks

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. — 2-weeks post-treatment