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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-09-30

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.

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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.

Conditions

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Candidiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Loading Dose

Group Type OTHER

Fluconazole Loading Dose

Intervention Type DRUG

Single Fluconazole loading dose 25 mg/kg

Loading & high dose

Loading dose \& high dose Fluconazole

Group Type OTHER

Fluconazole Loading Dose & High Dose

Intervention Type DRUG

Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days

Interventions

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Fluconazole Loading Dose

Single Fluconazole loading dose 25 mg/kg

Intervention Type DRUG

Fluconazole Loading Dose & High Dose

Fluconazole loading dose 25 mg/kg, followed by fluconazole 12 mg/kg q24 hours for total of 5 days

Intervention Type DRUG

Other Intervention Names

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Diflucan Diflucan

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

Minimum Eligible Age

48 Hours

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No