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Antifungal Prophylaxis in Pediatric Acute Leukemia

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ClinicalTrials.gov Identifier: NCT00624143
Recruitment Status : Unknown
Verified January 2008 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
First Posted : February 26, 2008
Last Update Posted : February 26, 2008
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi

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 convenience.

Condition or disease Intervention/treatment Phase
Pediatric Acute Leukemia Induction Drug: ORAL VORICONAZOLE and IV Amphotericin B Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : February 2008
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Prevention of possible, probable or proven fungal infection. [ Time Frame: Completion of Induction Chemotherapy or successful recovery of ANC > 1000/mm3 ]


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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: February 26, 2008
Last Verified: January 2008

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
Voriconazole
Amphotericin B
Liposomal amphotericin B
Antifungal Agents
Miconazole
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents
Cytochrome P-450 CYP2C9 Inhibitors