Candidiasis Clinical Trial
Official title:
A Phase III, Randomized, Double-Blind, Comparative Trial of FK463 Versus Fluconazole for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoetic Stem Cell Transplant
Fever and infection are serious complications of cancer treatment such as bone marrow
transplant, especially when white blood cell counts are low. When the number of white blood
cells is below 500, the person has a condition called neutropenia and has a high risk of
developing an infection. At the first sign of fever, antibiotics are started. However,
antibiotics do not kill fungus germs, and fungal infections may be difficult to treat. Thus,
the prevention of fungal infections in this population is important. The only medicine
approved for prevention of fungal infections is fluconazole, which prevents some but not all
types of such infections. A new antifungal medication called FK463 works against more types
of fungal infections than fluconazole does. This study will compare the effectiveness,
safety, and tolerance of FK463 as compared with fluconazole.
Eight hundred patients will be enrolled in this study. They will be randomly assigned to
receive either fluconazole or FK463. Before the medicine is begun, a physical exam as well
as a blood sample, mouth swab, urine sample, and chest x-ray will be done. The fluconazole
or FK463 will be administered once a day for one hour into the bloodstream through a
catheter in the vein. Blood tests will be taken twice a week. Cultures from the blood,
mouth, and urine will be taken throughout the study. X-rays and CT scans will only be taken
if a fungal infection is suspected. If fever develops, blood will be drawn to check for
fungi. If fever and neutropenia continue for more than 4 days, FK463 or fluconazole will be
stopped and a standard medication called amphotericin B will be started.
Both FK463 and fluconazole will be administered until white blood cell count returns to
greater than 500 (signifying recovery from neutropenia), or up to 42 days after
transplantation. Patients will be evaluated 4 weeks after the medicine is stopped.
The objective of this study is to determine the efficacy and safety of FK463 versus fluconazole in preventing fungal infections in patients undergoing an autologous (for hematologic malignancies) or allogeneic hematopoietic stem cell transplant. This is a Phase III, multicenter, randomized, double-blind study in patients six months of age and older. Study drug, either FK463 at 50 mg/day (1.0 mg/kg/day in patients weighing less than 50 kg) or fluconazole at 400 mg/day (8 mg/kg/day in patients weighing less than 50 kg), will be administered intravenously once daily in a blinded manner. Study drug will continue until neutrophil recovery (defined as a post nadir absolute neutrophil count (ANC) of greater than or equal to 500/mm3). Patients who develop a proven, probable, or suspected (requires empirical antifungal therapy) fungal infection will be discontinued from the prophylactic regimen. The maximum time the patient may receive study drug is 42 days post transplant. ;
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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