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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.


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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