Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children
CSF Pharmacokinetics of Antimicrobials in Children
2 other identifiers
observational
8
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 6, 2009
CompletedFirst Posted
Study publicly available on registry
October 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
July 16, 2014
CompletedApril 15, 2024
June 1, 2014
4.8 years
October 6, 2009
June 13, 2014
April 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CSF:Serum Ratio of Vancomycin
CSF:serum ration of vancomycin
within 1 week of drug administration
Eligibility Criteria
Children (\<18) receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care
You may qualify if:
- Children receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care
You may not qualify if:
- Lack of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related 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):e270-2. doi: 10.1097/INF.0000000000000385.
PMID: 24776517RESULT
Biospecimen
CSF, Blood, urine, bronchial, salivary, peritoneal, wound/abscess
MeSH Terms
Conditions
Results Point of Contact
- Title
- brian smith
- Organization
- duke
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2009
First Posted
October 7, 2009
Study Start
July 1, 2009
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
April 15, 2024
Results First Posted
July 16, 2014
Record last verified: 2014-06