A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)
- Registration Number
- NCT00379951
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 107
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ertapenem sodium Arm 1: ertapenem sodium
- Primary Outcome Measures
Name Time Method Safety and tolerability 14 Days
- Secondary Outcome Measures
Name Time Method Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment 14 days after treatment