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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

Tracking Information
First Submitted Date  ICMJE October 14, 2005
First Posted Date  ICMJE October 18, 2005
Last Update Posted Date May 25, 2012
Study Start Date  ICMJE June 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2005)		 Population pharmacokinetics
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2005)
  • Safety
  • Efficacy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gram-Positive Bacterial Infections
Intervention  ICMJE Drug: Synercid
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE January 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Serious, suspected or documented gram-positive infection

Exclusion Criteria:

-
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 27 Weeks to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00240747
Other Study ID Numbers  ICMJE RP59500V-324
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Aventis Pharmaceuticals
Investigators  ICMJE
Study Director: George Talbot, M.D. Yale University
PRS Account Pfizer
Verification Date May 2012

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