Status:
UNKNOWN
Antifungal Prophylaxis in Pediatric Acute Leukemia
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Pediatric Acute Leukemia Induction
Eligibility:
All Genders
Up to 15 years
Phase:
PHASE3
Brief 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 c...
Detailed Description
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 antifung...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00624143
Start Date
February 1 2008
Last Update
February 26 2008
Active Locations (1)
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1
Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029