Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00991185
First received: October 6, 2009
Last updated: June 13, 2014
Last verified: June 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:Serum Ratio of Vancomycin [ Time Frame: within 1 week of drug administration ] [ Designated as safety issue: No ]
    CSF:serum ration of vancomycin


Biospecimen Retention:   Samples With DNA

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


Enrollment: 8
Study Start Date: July 2009
Study Completion Date: April 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991185

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00991185     History of Changes
Other Study ID Numbers: Pro00013132, 5U10HD045962
Study First Received: October 6, 2009
Results First Received: June 13, 2014
Last Updated: June 13, 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 July 22, 2014