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

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ClinicalTrials.gov Identifier: NCT00797420
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : March 19, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Candidiasis Drug: Fluconazole Loading Dose Drug: Fluconazole Loading Dose & High Dose Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers
Study Start Date : November 2008
Primary Completion Date : January 2010
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections
Drug Information available for: Fluconazole
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Plasma concentration of Fluconazole [ Time Frame: 6-8 samples over 5 days ]

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00797420     History of Changes
Other Study ID Numbers: Pro00011454
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013

Keywords provided by Daniel Benjamin, Duke University Medical Center:
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