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

Phase 3

Terminated

• Conditions: Gram-Positive Bacterial Infections

• Registration Number: NCT00240747
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2000-06
• Study Completion: 2005-01
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-18
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-24
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Serious, suspected or documented gram-positive infection

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Population pharmacokinetics

Secondary Outcome Measures

Name	Time	Method
Safety
Efficacy

Trial Locations

Locations (5)

Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

The Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Children's Hospital at Saint Francis; 🇺🇸 Tulsa, Oklahoma, United States