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

This study has been completed.
Sponsor:
Collaborator:
Pediatric Pharmacology Research Units Network
Information provided by (Responsible Party):
Daniel Benjamin, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00797420
First received: November 23, 2008
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Candidiasis
Drug: Fluconazole Loading Dose
Drug: Fluconazole Loading Dose & High Dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Plasma concentration of Fluconazole [ Time Frame: 6-8 samples over 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: November 2008
Study Completion Date: September 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Loading Dose
Loading Dose
Drug: Fluconazole Loading Dose
Single Fluconazole loading dose 25 mg/kg
Other Name: Diflucan
Loading & high dose
Loading dose & high dose Fluconazole
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
Other Name: Diflucan

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.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00797420

Locations
United States, North Carolina
Duke Univeristy Medical Center
Durham, North Carolina, United States, 27715
Sponsors and Collaborators
Daniel Benjamin
Pediatric Pharmacology Research Units Network
Investigators
Principal Investigator: Lauren Piper, MD Duke University
  More Information

Publications:

Responsible Party: Daniel Benjamin, Professor of Pediatrics, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00797420     History of Changes
Other Study ID Numbers: Pro00011454, NIH-5U10-HD-045962-04
Study First Received: November 23, 2008
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
fluconazole
pharmacokinetic
candidiasis
sepsis
pediatric
infants
antifungal
candidemia
fungemia
loading dose

Additional relevant MeSH terms:
Candidiasis
Mycoses
Fluconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014