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

Condition(s) targeted: Urinary Tract Infections

Intervention: MK0826 (ertapenem) (Drug); Comparator: meropenem (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

Number of Participants With Serious Urinary Tract Infection With a Clinical Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)

Number of Participants With Serious Urinary Tract Infection With an Overall Microbiological Response to MK0826 Compared to Meropenem at Discontinuation of Intravenous Therapy (DCIV)

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

- 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

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: December 2008
Last updated: December 10, 2014