Antifungal Prophylaxis in Pediatric Acute Leukemia

This study is currently recruiting participants.

Verified by All India Institute of Medical Sciences, New Delhi, January 2008

First Received: February 19, 2008 No Changes Posted

Sponsored by:	All India Institute of Medical Sciences, New Delhi
Information provided by:	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00624143

Purpose

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.

Condition	Intervention	Phase
Pediatric Acute Leukemia Induction	Drug: ORAL VORICONAZOLE and IV Amphotericin B	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Oral Voriconazole vs IV Low Dose Amphotericin B for Primary Antifungal Prophylaxis in Pediatric Acute Leukemia Induction:A Prospective, Randomized, Clinical Trial.

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Childhood

Drug Information available for: Voriconazole Amphotericin B

U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:

Prevention of possible, probable or proven fungal infection. [ Time Frame: Completion of Induction Chemotherapy or successful recovery of ANC > 1000/mm3 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Oral Voriconazole	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
2: Active Comparator IV Amphotericin B	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

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Eligibility

Ages Eligible for Study:	up to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624143

Contacts

Contact: SAMEER BAKHSHI, MD

91-11-26588153

sambakh@hotmail.com

Locations

India, Delhi
Institute Rotary Cancer Hospital, All India Institute of Medical Sciences	Recruiting
New Delhi, Delhi, India, 110029
Contact: SAMEER BAKHSHI, MD 91-11-26588153 sambakh@hotmail.com

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Investigators

Principal Investigator:

SAMEER BAKHSHI, MD

Institute Rotary Cancer Hospital, All India Institute of Medical Sciences

More Information

No publications provided

Responsible Party:	Dr.Sameer Bakhshi ( Dr. Sameer Bakhshi, Associate Professor, Medical Oncology, IRCH, AIIMS, New Delhi )
Study ID Numbers:	antifungal prophylaxis, Dr. SAMEER BAKHSHI
Study First Received:	February 19, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00624143 History of Changes
Health Authority:	India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:

Antifungal prophylaxis, acute leukemia induction,

Study placed in the following topic categories:

Abelcet
Acute Disease
Anti-Bacterial Agents
Anti-Infective Agents
Amphotericin B

Leukemia
Antifungal Agents
Voriconazole
Liposomal amphotericin B

Additional relevant MeSH terms:

Acute Disease
Abelcet
Anti-Infective Agents
Amphotericin B
Disease Attributes
Antiprotozoal Agents
Neoplasms by Histologic Type
Liposomal amphotericin B
Pharmacologic Actions
Anti-Bacterial Agents

Leukemia
Antiparasitic Agents
Neoplasms
Pathologic Processes
Therapeutic Uses
Antifungal Agents
Voriconazole
Antibiotics, Antifungal
Amebicides

ClinicalTrials.gov processed this record on September 04, 2009