Oral Voriconazole vs IV Low Dose Amphotericin B for Primary Antifungal Prophylaxis in Pediatric Acute Leukemia Induction:A Prospective, Randomized, Clinical Trial.

NCT00624143 Phase 3 UNKNOWN

Hypothesis:Oral Voriconazole will be as effective as intravenous Amphotericin B as antifungal prophylaxis in induction of acute leukemia (ALL, AML) in pediatric patients, with less toxicity and more convenience.

Details

Lead sponsor	All India Institute of Medical Sciences
Phase	Phase 3
Status	UNKNOWN
Enrolment	100
Start date	2008-02

Conditions

• Pediatric Acute Leukemia Induction

Interventions

• ORAL VORICONAZOLE and IV Amphotericin B

Primary outcomes

• Prevention of possible, probable or proven fungal infection. — Completion of Induction Chemotherapy or successful recovery of ANC > 1000/mm3

Countries

India