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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240747
Recruitment Status : Terminated
First Posted : October 18, 2005
Last Update Posted : May 25, 2012
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Gram-Positive Bacterial Infections Drug: Synercid Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2000
Study Completion Date : January 2005
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Population pharmacokinetics

Secondary Outcome Measures :
  1. Safety
  2. Efficacy

Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Serious, suspected or documented gram-positive infection

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240747


Locations
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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
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Study Director: George Talbot, M.D. Yale University
More Information
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ClinicalTrials.gov Identifier: NCT00240747    
Other Study ID Numbers: RP59500V-324
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Bacterial Infections
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses
Infections
Quinupristin-dalfopristin
 Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action