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| ID | Type | Description | Link |
|---|---|---|---|
| 5U10HD045962 | U.S. NIH Grant/Contract | View source |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| CSF:Serum Ratio of Vancomycin | CSF:serum ration of vancomycin | within 1 week of drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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Children (<18) receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24776517 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vancomycin | children that received vancomycin per standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vancomycin | children that received vancomycin per standard of care |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | CSF:Serum Ratio of Vancomycin | CSF:serum ration of vancomycin | Posted | Median | Full Range | ratio | within 1 week of drug administration |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vancomycin | children that received vancomycin per standard of care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| brian smith | duke | 919668951 | brian.smith@duke.edu |
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| ID | Term |
|---|---|
| D007239 | Infections |
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CSF, Blood, urine, bronchial, salivary, peritoneal, wound/abscess
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 8 |
| 0 |
| 8 |
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