Overview

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