Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ceftriaxone; Ertapenem

Criteria

Inclusion Criteria:

• Adult patients with a suspected or documented complicated urinary tract infection

• Female patients must test negative for pregnancy and agree to use adequate birth control measures

• Nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy

Exclusion Criteria:

• Patients with complete obstruction of any portion of the urinary tract

• Patients with rapidly progressive or terminal illness

• Renal transplant patients