Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Tract Infections; Bacterial Pneumonia; Soft Tissue Infections
Intervention: MK0826, ertapenem sodium /Duration of Treatment: 14 Days (Drug); Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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: 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.
Eligibility
Minimum age: 3 Months.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Related publications: 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. doi: 10.1016/j.ijantimicag.2008.08.005. Epub 2008 Oct 21.
Starting date: January 2002
Last updated: November 12, 2014
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