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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00451386
First received: March 21, 2007
Last updated: February 20, 2009
Last verified: February 2009
History of Changes

March 21, 2007
February 20, 2009
January 2002
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00451386 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-Acquired Pneumonia
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • 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
Not Provided
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. Epub 2008 Oct 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
Not Provided
Not Provided

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
Both
3 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00451386
2007_525, MK0826-036
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP