Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated UTI

This study has been terminated.

( feasibility and low enrollment )

First Received: October 9, 2008 Last Updated: June 12, 2009 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00771316

Purpose

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.

Condition	Intervention	Phase
Urinary Tract Infections	Drug: ertapenem Drug: Comparator: meropenem	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Meropenem L 749345 Ertapenem

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Efficacy; Microbiological response assessment (MK0826 is noninferior to meropenem); MK0826 safety and tolerability. [ Time Frame: 5 to 9 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical and microbiological response assessment [ Time Frame: 4-14 days ] [ Designated as safety issue: No ]

Enrollment:	410
Study Start Date:	September 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental ertapenem	Drug: ertapenem A single dose of 1.0g IV infused over a 30 minute interval at hour 0
Group 2: Active Comparator meropenem	Drug: Comparator: meropenem 500 mg IV infused over a 30 minute interval at hours 0, 8, and 16 for at least 4 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771316

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_562, MK0826-054
Study First Received:	October 9, 2008
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00771316 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Urologic Diseases
Therapeutic Uses

Meropenem
Urinary Tract Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010