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

Merck Sharp & Dohme LLC400 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

400

Conditions

Urinary Tract Infections Bacterial Pneumonia Soft Tissue Infections

Interventions

MK0826, ertapenem sodium /Duration of Treatment: 14 DaysDRUG

Comparator: ceftriaxone sodium /Duration of Treatment: 14 DaysDRUG

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

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.

Data from ClinicalTrials.gov

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