Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated Urinary Tract Infection (0826-054)

Phase 3

Terminated

• Conditions: Urinary Tract Infections
• Interventions: Drug: MK0826 (ertapenem)

• Registration Number: NCT00771316
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to demonstrate that MK0826 is comparable to Meropenem in the treatment of complicated Urinary Tract Infections (UTIs) in adults.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-13
• Study Start: 2008-12
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-04-22
• Results First Submitted QC: 2010-06-14
• Results First Posted: 2010-07-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

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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
• Patient's 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	MK0826 (ertapenem)	MK0826 (ertapenem)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at the 5 to 9 Day Post Therapy Early Follow-up Visit	5 to 9 days post therapy	Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.
Number of Participants With Serious Urinary Tract Infection With a Clinical Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)	After at least 4 days of IV therapy	Clinical response at DCIV defined as: 1) Improved-All or most pretherapy signs and symptoms of infection have improved and no additional antibiotic is required, 2) Failure-No response to therapy, persistence or progression of pretherapy signs and symptoms, 3) Indeterminate-Study data not available due to complications related to underlying medical condition, patient withdrawn from study or extenuating circumstances preclude classification as improved or failure.
Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)	After at least 4 days of IV therapy	Microbiological response defined as: 1) Eradication-urine culture shows reduced uropathogen, 2)Persistence-urine culture taken after at least 2 days of therapy grows the original uropathogen, 3)Persistence with Acquisition of Resistance- urine culture taken after at least 2 days of therapy grows the original uropathogen but shows resistance to study drug, 4)Superinfection-Growth of uropathogen other than original pathogen, 5)New Infection-A new pathogen grows other than the original uropathogen, 6)Indeterminate-Any circumstance where impossible to define microbiological response.