Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001937
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Brief Title:
Comparing the Effectiveness of Fluconazole and a New Medicine FK463 in Preventing Fungal Infections in Bone Marrow Transplant Patients
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
1999-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 mgday 10 mgkgday in patients weighing less than 50 kg or fluconazole at 400 mgday 8 mgkgday 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 500mm3 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-C-0014 | None | None | None |