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

NCT00771316 | Terminated Phase 3 Results

• 3 other identifiers: 0826-054MK0826-0542008_562
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (3)

• 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.

  5 to 9 days post therapy

• 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3) Indeterminate-Study data not available due to complications related to underlying medical condition, patient withdrawn from study or extenuating circumstances preclude classification as improved or failure.

  After at least 4 days of IV therapy

• 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.

  After at least 4 days of IV therapy

Study Arms (2)

Group 1

EXPERIMENTAL

MK0826 (ertapenem)

Drug: MK0826 (ertapenem)

Group 2

ACTIVE COMPARATOR

meropenem

Drug: Comparator: meropenem

Interventions

MK0826 (ertapenem) DRUG

A single dose of 1.0g IV infused over a 30 minute interval at hour 0

Group 1

Comparator: meropenem DRUG

500 mg IV infused over a 30 minute interval at hours 0, 8, and 16 for at least 4 days

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The reason for early termination: Study was terminated early due to feasibility issues including slow enrollment.

Results Point of Contact

• Title: Vice President, Late Stage Development Group Leader
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2008
• First Posted: October 13, 2008
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 21, 2017
• Results First Posted: July 9, 2010

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share