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Antifungal Prophylaxis in Pediatric Acute Leukemia

NCT00624143 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-02-26

No results posted yet for this study

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.

Conditions

  • Pediatric Acute Leukemia Induction

Interventions

DRUG

ORAL VORICONAZOLE and IV Amphotericin B

Oral Voriconazole will be given in dose of 6mg/kg 12 hourly on day1 then 4mg/kg 12 hourly daily or IV Amphotericin B 0.5 mg/kg/day weekly thrice till the completion of induction or recovery of ANC \>1000/MM3 or development of fungal infection

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • SAMEER BAKHSHI, MD · Institute Rotary Cancer Hospital, All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624143 on ClinicalTrials.gov