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

RATIONALE OF STUDY:

• In induction chemotherapy for childhood acute leukemia, our experience and international studies has shown that 30% of ALL and approximately 50% of AML patients require antifungal therapy. Mortality rates associated with documented fungal infection due to opportunistic yeasts and filamentous fungi have been high, ranging from 50-90% despite use of therapeutic amphotericin B or voriconazole.
• Currently licensed drug for use in pediatric patients are amphotericin B and its lipid derivatives; 5-flucytosine; azoles like fluconazole, itraconazole, voriconazole; and caspofungin.
• Limitation with Fluconazole- inactive against Aspergilosis, C. glabrata, C. krusei, C. parapsilosis and filamentous fungi.
• Limitation with Itraconazole- erratic oral absorption of capsule form, frequent drug interactions, non availability of oral suspension form for use in very small children who would not be able to take capsules.
• Amphotericin B and Voriconazole both have proven activity against filamentous fungi and candida species.
• There is no prospective, randomised trial comparing voriconazole and amphotericin B in prophylaxis of pediatric acute leukemia during induction.

Hence there is need to study their role in prophylaxis of this infection which has a high mortality despite therapy.

Study design: Prospective, Randomized, concealed, single institutional study.

Study population: