Antifungal Prophylaxis in Pediatric Acute Leukemia

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Treatments: Amphotericin B; Antifungal Agents; Liposomal amphotericin B; Miconazole; Voriconazole

Criteria

Inclusion Criteria:

• Patients agechemotherapy.

• No evidence of fungal infection at randomization

• No pneumonia at presentation on CXR.

• No systemic antifungal therapy within 7 days before randomization.

Febrile patients with no pneumonia, systemic fungal infection and hemodynamically stable will be eligible for study.

Exclusion Criteria:

• Patients with baseline pneumonia on CXR.

• Laboratory evidence of significant hepatic or renal dysfunction (defined as a SGOT or SGPT >5 times, Total bilirubin>2 times and Serum creatinine > 2 times upper limit of normal)