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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00451386
First received: March 21, 2007
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  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

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00451386     History of Changes
Other Study ID Numbers: 2007_525, MK0826-036
Study First Received: March 21, 2007
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Urinary Tract Infections
Soft Tissue Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Infection
Urologic Diseases
Ceftriaxone
Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013