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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


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:




Minimum age: 27 Weeks. Maximum age: 16 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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