A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.

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

Details

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

Criteria

Inclusion Criteria:

• Patient has a complicated urinary tract infection

• Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture

• Patient is indian and 18 years of age or greater.

Exclusion Criteria:

• Patient had a kidney transplant

• Patient had been given antibiotic therapy for condition

• Patient had poor liver function

• Patient has complete obstruction of urinary tract

• Patient has history of serious allergy to antibiotics and multivitamins

• Patient is pregnant

• Patient not likely to respond to 10 to 14 days of antibiotic therapy

• Patient not likely to survive 4 week study period