InfectionsNCT00991185
Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children
An observational study of Infections, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Infections
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Apr 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children (<18) receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care
Who may be able to join
- Children receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care
Who cannot join
- Lack of consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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.
- Conditions
- Infections
- Keywords
- Infections in Children
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF:Serum Ratio of Vancomycin
CSF:serum ration of vancomycin
Measured: within 1 week of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991185
- Sponsor's protocol ID
- Pro00013132
- Other IDs
- 5U10HD045962
- Status last verified
- Jun 2014
- First submitted
- 6 Oct 2009
- Last updated
- 15 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24776517
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSF Pharmacokinetics of Antimicrobials in Children
- ClinicalTrials.gov ID
- NCT00991185
- Acronym / sponsor ID
- Pro00013132
- Conditions
- Infections
- Keywords
- Infections in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Posted 16 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children (<18) receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care
Key inclusion criteria (1 listed)
- Children receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care
Key exclusion criteria (1 listed)
- Lack of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CSF:Serum Ratio of Vancomycin
Time frame: within 1 week of drug administration
CSF:serum ration of vancomycin
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24776517Autmizguine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF:Serum Ratio of Vancomycin (time frame: within 1 week of drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00991185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.