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Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

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 (MK0826) (Drug); Comparator: ceftriaxone 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 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.

Clinical Details

Official title: A Prospective, Multicenter, Partially-Blinded, Randomized, Comparative Study to Evaluate the Safety, Tolerability and Efficacy of INVANZ Versus Ceftriaxone Sodium in the Treatment of Complicated Urinary Tract Infections in Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Microbiological Response Assessment Profile

The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment

Secondary outcome: Clinical Response Assessment Profile


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


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

Locations and Contacts

Additional Information

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: April 2008
Last updated: July 6, 2015

Page last updated: August 23, 2015

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