Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers

Study Overview
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Brief Summary
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The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.

Detailed Description
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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.

Official Title
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Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers

Conditions
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Candidiasis

Intervention / Treatment
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* Drug: Fluconazole Loading Dose
* Drug: Fluconazole Loading Dose & High Dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suspected sepsis with blood culture within 48 hours age ≥ 48 hours and < 2 years of age sufficient venous access to permit study drug administration Exclusion Criteria: allergic reaction to azole history of fluconazole administration in prior 5 days liver dysfunction renal failure concomitant use of cyclosporine, tacrolimus, or azithromycin

Ages Eligible for Study
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Minimum Age: 48 Hours
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Loading Dose<br>Loading Dose | Drug: Fluconazole Loading Dose<br>* Single Fluconazole loading dose 25 mg/kg<br>* Other names: Diflucan;|
| Other: Loading & high dose<br>Loading dose & high dose Fluconazole | Drug: Fluconazole Loading Dose & High Dose<br>* Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days<br>* Other names: Diflucan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of Fluconazole |  | 6-8 samples over 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluconazole, pharmacokinetic, candidiasis, sepsis, pediatric, infants, antifungal, candidemia, fungemia, loading dose