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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

November 23, 2008
March 18, 2013
November 2008
January 2010   (final data collection date for primary outcome measure)
Plasma concentration of Fluconazole [ Time Frame: 6-8 samples over 5 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00797420 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers
Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers

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

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Candidiasis
  • Drug: Fluconazole Loading Dose
    Single Fluconazole loading dose 25 mg/kg
    Other Name: Diflucan
  • 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
  • Loading Dose
    Loading Dose
    Intervention: Drug: Fluconazole Loading Dose
  • Loading & high dose
    Loading dose & high dose Fluconazole
    Intervention: Drug: Fluconazole Loading Dose & High Dose

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
September 2011
January 2010   (final data collection date for primary outcome measure)

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
Both
up to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00797420
Pro00011454, NIH-5U10-HD-045962-04
No
Daniel Benjamin, Duke University Medical Center
Daniel Benjamin
Pediatric Pharmacology Research Units Network
Principal Investigator: Lauren Piper, MD Duke University
Duke University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP