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An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092170
First received: September 21, 2004
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.


Condition Intervention Phase
Infections
Pelvic Infections
 Drug: MK0826, ertapenem sodium
Drug: Comparator: Ticarcillin/Clavulanate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Ertapenem Sodium ( MK0826) Versus Ticarcillin/Clavulanate in the Treatment of Hospital-Acquired Pneumonia, Complicated Intra-Abdominal Infections, and Acute Pelvic Infections in Pediatric Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy

Estimated Enrollment: 100
Study Start Date: January 2002
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Detailed Description:

The duration of treatment is 18 months.

  Eligibility

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

Inclusion Criteria:

  • Patients aged 3 months to 17 years with intra-abdominal infection or acute pelvic infection

Exclusion Criteria:

  • Immune problems
  • Kidney problems
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092170

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00092170     History of Changes
Other Study ID Numbers: 2004_062
Study First Received: September 21, 2004
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Intra-abdominal infections
Acute pelvic infections

Additional relevant MeSH terms:
Pelvic Infection
Pelvic Inflammatory Disease
Infection
Adnexal Diseases
Genital Diseases, Female
Ticarcillin
Clavulanic Acids
Clavulanic Acid
 Ertapenem
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013