Official 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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: MK0826, ertapenem sodium /Duration of Treatment: 14 Days
• Drug: Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days

Primary Measures

• 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 Measures

• 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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Months

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00451386

Study ID Number: 2007_525

ClinicalTrials.gov Identifier: NCT00451386

Health Authority: United States: Food and Drug Administration