Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children

This study is currently recruiting participants.
Verified March 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00991185
First received: October 6, 2009
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition
Infections

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: CSF Pharmacokinetics of Antimicrobials in Children

Further study details as provided by Duke University:

Primary Outcome Measures:
  • CSF levels of drugs in children [ Time Frame: within 1 week of drug administration ] [ Designated as safety issue: No ]
    measure levels of drugs in the CSF of children


Biospecimen Retention:   Samples With DNA

CSF, Blood, urine, bronchial, salivary, peritoneal, wound/abscess


Estimated Enrollment: 500
Study Start Date: July 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children (<18) receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care

Criteria

Inclusion Criteria:

  • Children receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care

Exclusion Criteria:

  • Lack of consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991185

Contacts
Contact: Kimberley Fisher, PhD 919-681-4913 Kimberley.fisher@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Kimberley Fisher, PhD    919-681-4913    kimberley.fisher@duke.edu   
Principal Investigator: Brian Smith, MD         
Sponsors and Collaborators
Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00991185     History of Changes
Other Study ID Numbers: Pro00013132, 5U10HD045962
Study First Received: October 6, 2009
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Infections in Children

Additional relevant MeSH terms:
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014