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.
Summary
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 ProfileThe 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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