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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Benjamin
• Collaborator: Pediatric Pharmacology Research Units Network
• Treatments: Fluconazole

Criteria

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