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NCT00240747 Clinical Trial

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

Gram-Positive Bacterial Infections Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00240747
Other study ID # RP59500V-324
Secondary ID
Status Terminated
Phase Phase 3
First received October 14, 2005
Last updated May 24, 2012
Start date June 2000
Est. completion date January 2005

Study information
Verified date May 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date January 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 27 Weeks to 16 Years
Eligibility Inclusion Criteria:

- Serious, suspected or documented gram-positive infection

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Synercid

Locations
Country Name City State
United States Children's Hospital Cincinnati Ohio
United States The Cleveland Clinic Cleveland Ohio
United States Duke University Medical Center Durham North Carolina
United States Children's Hospital Oakland California
United States Children's Hospital of Orange County Orange California
United States Children's Hospital at Saint Francis Tulsa Oklahoma

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Population pharmacokinetics
Secondary Safety
Secondary Efficacy
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