Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

Phase 3

Completed

• Conditions: Urinary Tract Infection
• Interventions: Drug: ertapenem sodium (MK0826)

• Registration Number: NCT01014013
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-16
• Results First Submitted: 2010-01-19
• Results First Submitted QC: 2010-02-12
• Results First Posted: 2010-03-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

Inclusion Criteria

• Adult patients with a suspected or documented complicated urinary tract infection
• Female patients must test negative for pregnancy and agree to use adequate birth control measures
• Nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy

Exclusion Criteria

• Patients with complete obstruction of any portion of the urinary tract
• Patients with rapidly progressive or terminal illness
• Renal transplant patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ertapenem sodium (MK0826)	ertapenem sodium (MK0826)	ertapenem sodium

Primary Outcome Measures

Name	Time	Method
The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment	Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days	Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.
Microbiological Response Assessment Profile	5 to 9 days post-therapy	The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed

Secondary Outcome Measures

Name	Time	Method
Clinical Response Assessment Profile	5 to 9 days post-therapy	The difference in favorable clinical response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed