Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)

Phase 2

Completed

• Conditions: Soft Tissue Infections; Urinary Tract Infections; Bacterial Pneumonia

• Registration Number: NCT00451386
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will investigate the safety and efficacy of ertapenem versus ceftriaxone in pediatric patients with urinary tract infections, skin infections, or community-acquired pneumonia.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2007-03-21
• Study First Submitted QC: 2007-03-21
• Study First Posted: 2007-03-23
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients with UTI must have white blood cells and bacteria in the urine with bladder catheterization or urologic abnormality, kidney infection or both
• Patients with SSTI must have a recent infection
• Patients with CAP must have a chest x-ray indicating bacterial pneumonia and a fever

Read More

Exclusion Criteria

• Patients with complete urinary tract blockage or kidney abscess
• Patients with infected burn wounds, bone infection, or bacterial arthritis
• Patients on mechanical ventilation or those with cystic fibrosis, chronic lung disease or puss in the space between the chest wall and lung

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the incidence of any clinical and/or laboratory drug-related serious adverse experience during the parenteral therapy period in pediatric patients treated with ertapenem.

Secondary Outcome Measures

Name	Time	Method
To compare the safety of ertapenem versus ceftriaxone during the parenteral therapy period with respect to the proportion of patients with any drug-related adverse experiences in pediatric patients with UTI, SSTI, or CAP.