Status:
COMPLETED
Pharmacokinetics (PK) Study of a Fluconazole Loading Dose in Infants and Toddlers
Lead Sponsor:
Daniel Benjamin
Collaborating Sponsors:
Pediatric Pharmacology Research Units Network
Conditions:
Candidiasis
Eligibility:
All Genders
48-2 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the pharmacokinetics and safety of a fluconazole loading dose in infants and toddlers.
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 ...
Eligibility Criteria
Inclusion
- 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
- allergic reaction to azole
- history of fluconazole administration in prior 5 days
- liver dysfunction
- renal failure
- concomitant use of cyclosporine, tacrolimus, or azithromycin
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00797420
Start Date
November 1 2008
End Date
September 1 2011
Last Update
November 5 2018
Active Locations (1)
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1
Duke Univeristy Medical Center
Durham, North Carolina, United States, 27715