A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Tract Infection
Intervention: ertapenem sodium (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: A Prospective, Multicenter, Noncomparative, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Safety and tolerability
Secondary outcome: Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: June 2005
Last updated: December 1, 2014
|
