Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
1 other identifier
interventional
N/A
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2000
Longer than P75 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedMay 25, 2012
May 1, 2012
October 14, 2005
May 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Population pharmacokinetics
Secondary Outcomes (2)
Safety
Efficacy
Interventions
Eligibility Criteria
You may qualify if:
- Serious, suspected or documented gram-positive infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Aventis Pharmaceuticalscollaborator
Study Sites (6)
Children's Hospital
Oakland, California, 94609, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Children's Hospital
Cincinnati, Ohio, 45267, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Children's Hospital at Saint Francis
Tulsa, Oklahoma, 74136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
George Talbot, M.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 18, 2005
Study Start
June 1, 2000
Study Completion
January 1, 2005
Last Updated
May 25, 2012
Record last verified: 2012-05