Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)
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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 Start Date
Primary Completion Date
Study Completion Date
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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
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.
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Ages Eligible for Study:
3 Months to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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