Infections
Conditions
Keywords
Infections in Children
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.
Interventions
None listed
Sponsors
Duke University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care
Exclusion criteria
* Lack of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSF:Serum Ratio of Vancomycin | within 1 week of drug administration | CSF:serum ration of vancomycin |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vancomycin children that received vancomycin per standard of care | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Vancomycin |
|---|---|
| Age, Continuous | 4 years |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
CSF:Serum Ratio of Vancomycin
CSF:serum ration of vancomycin
Time frame: within 1 week of drug administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vancomycin | CSF:Serum Ratio of Vancomycin | 0.08 ratio |