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

This study has been completed.
Pediatric Pharmacology Research Units Network
Information provided by (Responsible Party):
Daniel Benjamin, Duke University Medical Center Identifier:
First received: November 23, 2008
Last updated: March 18, 2013
Last verified: March 2013
The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 ]

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.

Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00797420

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


Responsible Party: Daniel Benjamin, Professor of Pediatrics, Duke University Medical Center Identifier: NCT00797420     History of Changes
Other Study ID Numbers: Pro00011454
Study First Received: November 23, 2008
Last Updated: March 18, 2013

Keywords provided by Duke University:
loading dose

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors processed this record on May 24, 2017