Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT00797420
Status:
COMPLETED
Last Update Posted:
2018-11-05
First Post:
2008-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers
Sponsor:
Daniel Benjamin
Organization:
Study Overview
Official Title:
Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.
Detailed Description:
This is an open label study to investigative the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers \< 2 years of age with suspected sepsis. There will be two treatment groups: single fluconazole loading dose 25 mg/kg; fluconazole loading dose 25mg/kg followed by 12 mg/kg daily for total of 5 days. There will be three age cohorts within each group: pre-term \< 30 week EGA infants \> 48 hours and \< 31 days; \> 30 weeks EGA infants \> 48 hours and \< 31 days; infants ≥ 31 days and \< 2 years of age. The study requires administration of fluconazole over 1-5 days depending on treatment group followed by 1 week of safety monitoring. Six to eight 100 µL PK samples will be obtained over the 5 days of drug administration. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of empirical antifungal therapy), and information from the study may benefit a large number of other infants and toddlers with suspected or proven fungal sepsis. There is a data analysis plan.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NIH-5U10-HD-045962-04 | None | None | View |