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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.
Aventis Pharmaceuticals
Information provided by:
Pfizer Identifier:
First received: October 14, 2005
Last updated: May 24, 2012
Last verified: May 2012
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
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

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

Ages Eligible for Study:   27 Weeks to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Serious, suspected or documented gram-positive infection

Exclusion Criteria:

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

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
Aventis Pharmaceuticals
Study Director: George Talbot, M.D. Yale University
  More Information Identifier: NCT00240747     History of Changes
Other Study ID Numbers: RP59500V-324
Study First Received: October 14, 2005
Last Updated: May 24, 2012

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 16, 2017