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

Completed · Phase 1

Conditions studied: Candidiasis

In brief

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

Key facts

Study ID

NCT00797420

Run by

Daniel Benjamin

People needed

13

Starts

2008-11-01

Expected to finish

2011-09-01

Last updated by the study team

2018-11-05

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• suspected sepsis with blood culture within 48 hours
• age ≥ 48 hours and < 2 years of age
• sufficient venous access to permit study drug administration

You may not qualify if…

• allergic reaction to azole
• history of fluconazole administration in prior 5 days
• liver dysfunction
• renal failure
• concomitant use of cyclosporine, tacrolimus, or azithromycin

Where it is running

• Duke Univeristy Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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