Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children

April 11, 2024 updated by: Duke University

CSF Pharmacokinetics of Antimicrobials in Children

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Lack of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CSF:Serum Ratio of Vancomycin
Time Frame: within 1 week of drug administration
CSF:serum ration of vancomycin
within 1 week of drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

October 6, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (Estimated)

October 7, 2009

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00013132
  • 5U10HD045962 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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