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Antifungal Prophylaxis in Pediatric Acute Leukemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00624143
First Posted: February 26, 2008
Last Update Posted: February 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
All India Institute of Medical Sciences, New Delhi
  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 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


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 ]

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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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)
  Contacts and Locations
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
  More Information

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 Submitted: February 19, 2008
First Posted: February 26, 2008
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