Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gram-Positive Bacterial Infections
Intervention: Synercid (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
George Talbot, M.D., Study Director, Affiliation: Yale University
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.
Clinical Details
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Population pharmacokinetics
Secondary outcome: SafetyEfficacy
Eligibility
Minimum age: 27 Weeks.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Serious, suspected or documented gram-positive infection
Exclusion Criteria:
-
Locations and Contacts
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
Additional Information
Starting date: June 2000
Last updated: May 24, 2012
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