At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 13 enrolled
Drug / intervention
Fluconazole Loading Dose +1 moredrug
Likely dose
Fluconazole Loading Dose 25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers
In Brief
A Phase 1 clinical trial evaluating Fluconazole Loading Dose and Fluconazole Loading Dose & High Dose for Candidiasis. Completed, enrolled 13 participants across 1 site.
Detailed Summary
The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCandidiasis
CountriesUnited States
CollaboratorsPediatric Pharmacology Research Units Network
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedNov 2008
Primary CompletionJan 2010
Study CompletionSep 2011
TodayJul 2026
First PostedNov 25, 2008
Enrollment StartNov 1, 2008
Primary CompletionJan 1, 2010
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.6 years ago
Interventions
Fluconazole Loading Dosedrug
Single Fluconazole loading dose 25 mg/kg
Fluconazole Loading Dose & High Dosedrug
Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days