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

NCT00240747 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-05-25

No results posted yet for this study

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.

Conditions

  • Gram-Positive Bacterial Infections

Interventions

DRUG

Synercid

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • George Talbot, M.D. · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
27 Weeks
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-06-30
Completion
2005-01-31

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00240747 on ClinicalTrials.gov