drugset / Trial / NCT00624143
Antifungal Prophylaxis in Pediatric Acute Leukemia
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2008-02
- Primary completion
- 2009-12
- Completion
- —
Publications
- Mandhaniya S, Iqbal S, Sharawat SK, Xess I, Bakhshi S. Diagnosis of invasive fungal infections using real-time PCR assay in paediatric acute leukaemia induction. Mycoses. 2012 Jul;55(4):372-9. doi: 10.1111/j.1439-0507.2011.02157.x. Epub 2012 Mar 16.
- Mandhaniya S, Swaroop C, Thulkar S, Vishnubhatla S, Kabra SK, Xess I, Bakhshi S. Oral voriconazole versus intravenous low dose amphotericin B for primary antifungal prophylaxis in pediatric acute leukemia induction: a prospective, randomized, clinical study. J Pediatr Hematol Oncol. 2011 Dec;33(8):e333-41. doi: 10.1097/MPH.0b013e3182331bc7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amphotericin B | Unknown | 0.5 mg/kg | Intravenous |
| Comparator | Voriconazole | Small molecule | 4 mg/kg | Oral |