Clinical trial · Interventional
Antifungal Prophylaxis in Pediatric Acute Leukemia
Oral Voriconazole vs IV Low Dose Amphotericin B for Primary Antifungal Prophylaxis in Pediatric Acute Leukemia Induction:A Prospective, Randomized, Clinical Trial.
NCT00624143CI-TRIAL-00001164unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Acute Leukemia Induction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ORAL VORICONAZOLE and IV Amphotericin B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Oral Voriconazole
- interventionNames
- Drug: ORAL VORICONAZOLE and IV Amphotericin B
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- IV Amphotericin B
- interventionNames
- Drug: ORAL VORICONAZOLE and IV Amphotericin B
Primary outcomes (1)
- measure
- Prevention of possible, probable or proven fungal infection.
- timeFrame
- Completion of Induction Chemotherapy or successful recovery of ANC > 1000/mm3
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Patients age \</= 15 years with de novo acute leukemia (AML, ALL) undergoing induction chemotherapy. * 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)
References
Publications (2)
- DERIVEDMandhaniya 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. PMID 22420668
- DERIVEDMandhaniya 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. PMID 22042283