Back to resultsClinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated Urinary Tract Infection (0826-054)
Primary Purpose
Urinary Tract Infections
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0826 (ertapenem)
Comparator: meropenem
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infections
Eligibility 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
MK0826 (ertapenem)
meropenem
Outcomes
Primary Outcome Measures
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
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)
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00771316
First Posted
October 9, 2008
Last Updated
February 14, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00771316
Brief Title
Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated Urinary Tract Infection (0826-054)
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 Urinary Tract Infection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
feasibility and low enrollment
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
MK0826 (ertapenem)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
meropenem
Intervention Type
Drug
Intervention Name(s)
MK0826 (ertapenem)
Intervention Description
A single dose of 1.0g IV infused over a 30 minute interval at hour 0
Intervention Type
Drug
Intervention Name(s)
Comparator: meropenem
Intervention Description
500 mg IV infused over a 30 minute interval at hours 0, 8, and 16 for at least 4 days
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
5 to 9 days post therapy
Title
Number of Participants With Serious Urinary Tract Infection With a Clinical Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)
Description
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.
Time Frame
After at least 4 days of IV therapy
Title
Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)
Description
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.
Time Frame
After at least 4 days of IV therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated Urinary Tract Infection (0826-054)
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