Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections 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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: MK0826, ertapenem sodium /Duration of Treatment: 14 Days
- Drug: Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days
Outcome Measures for this Clinical Trial
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.
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Arguedas A, Cespedes J, Botet FA, Blumer J, Yogev R, Gesser R, Wang J, West J, Snyder T, Wimmer W; Protocol 036 Study Group. Safety and tolerability of ertapenem versus ceftriaxone in a double-blind study performed in children with complicated urinary tract infection, community-acquired pneumonia or skin and soft-tissue infection. Int J Antimicrob Agents. 2009 Feb;33(2):163-7. Epub 2008 Oct 21.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00451386
