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Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients

This study has been terminated.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00240747
First received: October 14, 2005
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  Purpose

Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population pharmacokinetics of Synercid in pediatric patients and to collect additional safety and efficacy data in pediatric patients.


Condition Intervention Phase
Gram-Positive Bacterial Infections
 Drug: Synercid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Population pharmacokinetics

Secondary Outcome Measures:
  • Safety
  • Efficacy

Study Start Date: June 2000
Estimated Study Completion Date: January 2005
  Eligibility

Ages Eligible for Study:   27 Weeks to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serious, suspected or documented gram-positive infection

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240747

Locations
United States, California
Children's Hospital
Oakland, California, United States, 94609
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
Children's Hospital
Cincinnati, Ohio, United States, 45267
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Children's Hospital at Saint Francis
Tulsa, Oklahoma, United States, 74136
Sponsors and Collaborators
Pfizer
Aventis Pharmaceuticals
Investigators
Study Director: George Talbot, M.D. Yale University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00240747     History of Changes
Other Study ID Numbers: RP59500V-324
Study First Received: October 14, 2005
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Quinupristin-dalfopristin
Anti-Bacterial Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013