Open-Label, Multiple-Dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients

This study has been terminated.

First Received: October 14, 2005 No Changes Posted

Sponsors and Collaborators:	King Pharmaceuticals Aventis Pharmaceuticals
Information provided by:	King Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00240747

Purpose

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.

Condition	Intervention	Phase
Gram-Positive Bacterial Infections	Drug: Synercid	Phase III

MedlinePlus related topics: Bacterial Infections

Drug Information available for: RP 59500

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Further study details as provided by King Pharmaceuticals:

Primary Outcome Measures:

Population pharmacokinetics

Secondary Outcome Measures:

Safety
Efficacy

Study Start Date:	June 2000
Estimated Study Completion Date:	January 2005

Eligibility

Ages Eligible for Study:	27 Weeks to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Serious, suspected or documented gram-positive infection

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240747

Locations

United States, California
Children's Hospital
Oakland, California, United States, 94609
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
Children's Hospital
Cincinnati, Ohio, United States, 45267
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Children's Hospital at Saint Francis
Tulsa, Oklahoma, United States, 74136

Sponsors and Collaborators

King Pharmaceuticals

Aventis Pharmaceuticals

Investigators

Study Director:

George Talbot, M.D.

Yale University

More Information

No publications provided

Study ID Numbers:	RP59500V-324
Study First Received:	October 14, 2005
Last Updated:	October 14, 2005
ClinicalTrials.gov Identifier:	NCT00240747 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Quinupristin-dalfopristin

Additional relevant MeSH terms:

Bacterial Infections
Protein Synthesis Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Quinupristin-dalfopristin

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009