Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-Acquired Pneumonia - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00451386

Purpose

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.

Condition	Intervention	Phase
Urinary Tract Infections Bacterial Pneumonia Soft Tissue Infections	Drug: MK0826, ertapenem sodium /Duration of Treatment: 14 Days Drug: Comparator: ceftriaxone sodium /Duration of Treatment: 14 Days	Phase II

MedlinePlus related topics: Dietary Sodium Pneumonia Urinary Tract Infections

Drug Information available for: Ceftriaxone Ceftriaxone Sodium Ertapenem L 749345

U.S. FDA Resources

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

Further study details as provided by Merck:

Primary Outcome 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 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.

Estimated Enrollment:	400
Study Start Date:	January 2002

Eligibility

Ages Eligible for Study:	3 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451386

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2007_525
Study First Received:	March 21, 2007
Last Updated:	March 21, 2007
ClinicalTrials.gov Identifier:	NCT00451386
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ertapenem
Bacterial Infections
Skin Diseases, Infectious
Soft Tissue Infections
Urologic Diseases
Respiratory Tract Infections

Respiratory Tract Diseases
Lung Diseases
Pneumonia, Bacterial
Urinary Tract Infections
Ceftriaxone
Pneumonia

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009