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

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.

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Key information

Conditions

Urinary Tract Infections Bacterial Infections Bacterial Infections and Mycoses Bacterial Pneumonia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Lung Diseases Male Urogenital Diseases Pneumonia Pneumonia, Bacterial Respiratory Tract Diseases Respiratory Tract Infections Soft Tissue Infections Urogenital Diseases Urologic Diseases

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

MK0826, ertapenem sodium /Duration of Treatment: 14 Days

Drug

Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days

Drug

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Local Tolerability, and Clinical Outcome of Ertapenem Versus Ceftriaxone in Pediatric Patients With Complicated Urinary Tract Infection, Skin and Soft Tissue Infection, or Community-Acquired Pneumonia

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Mar 23, 2007
Registry last updated: Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting