Trial Outcomes & Findings for Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children (NCT NCT00991185)
NCT ID: NCT00991185
Last Updated: 2024-04-15
Results Overview
CSF:serum ration of vancomycin
Recruitment status
COMPLETED
Target enrollment
8 participants
Primary outcome timeframe
within 1 week of drug administration
Results posted on
2024-04-15
Participant Flow
Participant milestones
| Measure |
Vancomycin
children that received vancomycin per standard of care
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children
Baseline characteristics by cohort
| Measure |
Vancomycin
n=8 Participants
children that received vancomycin per standard of care
|
|---|---|
|
Age, Continuous
|
4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 1 week of drug administrationCSF:serum ration of vancomycin
Outcome measures
| Measure |
Vancomycin
n=8 Participants
children that received vancomycin per standard of care
|
|---|---|
|
CSF:Serum Ratio of Vancomycin
|
0.08 ratio
Interval 0.0 to 0.66
|
Adverse Events
Vancomycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place