Status:
COMPLETED
Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Cancer
Eligibility:
All Genders
12-120 years
Phase:
NA
Brief Summary
RATIONALE: Antifungals, such as voriconazole and itraconazole, may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation. PURPOSE: This rand...
Detailed Description
OBJECTIVES: * Compare the safety and tolerability of voriconazole vs itraconazole for the prevention of fungal infections in patients undergoing allogeneic hematopoietic stem cell transplantation. O...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Undergoing allogeneic hematopoietic stem cell transplantation
- No invasive yeast infection within the past 8 weeks
- Colonized or superficial infection allowed
- No documented or probable aspergillus or mold infection within the past 8 weeks
- Patients with a history of candidemia must have negative blood cultures and no clinical signs of candidemia
- PATIENT CHARACTERISTICS:
- Age
- 12 and over
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior allergy or intolerance to imidazoles or azoles (e.g., fluconazole, itraconazole, voriconazole, ketoconazole, miconazole, or clotrimazole)
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- See Disease Characteristics
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- At least 1 week since prior amphotericin B or fluconazole for candidemia
- No concurrent therapy with any of the following:
- Rifampin
- Rifabutin
- Phenobarbital
- Phenytoin
- Carbamazepine
- Oral midazolam
- Triazolam
- Terfenadine
- Astemizole
- Concurrent topical antifungal agents for superficial fungal infections allowed
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00079222
Start Date
November 1 2003
Last Update
August 3 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1678