Antifungal Prophylaxis in Pediatric Acute Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by All India Institute of Medical Sciences, New Delhi. Recruitment status was Recruiting

First Received on February 19, 2008. No Changes Posted

Sponsor:	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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

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
Active Comparator: 1 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
Active Comparator: 2 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
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 by All India Institute of Medical Sciences, New Delhi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

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

Antifungal prophylaxis, acute leukemia induction,

Additional relevant MeSH terms:

Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Voriconazole

Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012