Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated UTI
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Tract Infections
Intervention: ertapenem (Drug); Comparator: meropenem (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
The purpose of this study is to demonstrate that MK0826 is comparable to Meropenem in the
treatment of complicated UTIs (urinary tract infections) in adults.
Clinical Details
Official title: A Phase 3, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK0826 and Meropenem in Patients With Complicated UTI
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy; Microbiological response assessment (MK0826 is non-inferior to meropenem); MK0826 safety and tolerability.
Secondary outcome: Clinical and microbiological response assessment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient has a clinically suspected and /or bacteriologically documented complicated
UTI or acute pyelonephritis judged by the investigator to be serious
- Patient has one positive urine culture within 48 hours of enrollment
- Patient has one or more signs or symptoms of either upper or lower UTI
- Patient is male with or without a bladder catheter or urologic abnormalities; OR
patient is a female with a history or clinical evidence of one or more urologic
abnormalities
Exclusion Criteria:
- Patient has received any amount of effective concomitant antibiotic therapy after
obtaining the urine culture for admission to this study (admission urine culture) and
prior to the administration of the first dose of study antibiotics
- Patients infection has been treated with greater than 24 hours of systemic antibiotic
therapy known to be effective against the presumed or documented pathogens within the
72 hour period immediately prior to consideration for entry into the study
- Patient has complete obstruction of any portion of the urinary tract. Patient has a
history of seizures other than an uncomplicated febrile seizure
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information, Haleyville, Alabama 35565, United States; Recruiting
Call for Information, Pasadena, California 91105, United States; Recruiting
Call for Information, Los Angeles, California 90015, United States; Recruiting
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Starting date: September 2008
Ending date: November 2009
Last updated: January 8, 2009
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