Back to resultsOpen-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
Primary Purpose
Gram-Positive Bacterial Infections
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Synercid
Sponsored by
About this trial
This is an interventional treatment trial for Gram-Positive Bacterial Infections
Eligibility Criteria
Inclusion Criteria: Serious, suspected or documented gram-positive infection Exclusion Criteria: -
Sites / Locations
- Children's Hospital
- Children's Hospital of Orange County
- Duke University Medical Center
- Children's Hospital
- The Cleveland Clinic
- Children's Hospital at Saint Francis
Outcomes
Primary Outcome Measures
Population pharmacokinetics
Secondary Outcome Measures
Safety
Efficacy
Full Information
NCT ID
NCT00240747
First Posted
October 14, 2005
Last Updated
May 24, 2012
Sponsor
Pfizer
Collaborators
Aventis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00240747
Brief Title
Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
Collaborators
Aventis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Positive Bacterial Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Synercid
Primary Outcome Measure Information:
Title
Population pharmacokinetics
Secondary Outcome Measure Information:
Title
Safety
Title
Efficacy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
27 Weeks
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Serious, suspected or documented gram-positive infection
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Talbot, M.D.
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Children's Hospital at Saint Francis
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
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