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NCT00991185 Clinical Trial

Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children

Infections Clinical Trial

Official title:
CSF Pharmacokinetics of Antimicrobials in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00991185
Other study ID # Pro00013132
Secondary ID 5U10HD045962
Status Completed
Phase
First received
Last updated
Start date July 2009
Est. completion date April 2014

Study information
Verified date June 2014
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to learn more about antimicrobials, especially drug levels in the CSF that would normally be used in young children as part of standard care. These drugs are approved by the Food and Drug Administration (FDA) for treating infections. They are used extensively in children in the United States, but they have not been extensively studied in children or babies. The investigators do not have very much information on how children and babies handle these drugs; that is, how long it takes for the drugs to be removed from the blood circulation and to pass out of the body and how much goes into the central nervous system. The investigators also do not have good information to guide how often the investigators should give the drugs to children and babies to get the maximum effect on infections with the minimum amount of drug. Thus, the investigators will collect more information about how these drugs should be used in children and babies by doing this drug levels research study.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Children receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care Exclusion Criteria: - Lack of consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Autmizguine J, Moran C, Gonzalez D, Capparelli EV, Smith PB, Grant GA, Benjamin DK Jr, Cohen-Wolkowiez M, Watt KM. Vancomycin cerebrospinal fluid pharmacokinetics in children with cerebral ventricular shunt infections. Pediatr Infect Dis J. 2014 Oct;33(10 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary CSF:Serum Ratio of Vancomycin CSF:serum ration of vancomycin within 1 week of drug administration
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