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NCT00001937 · ClinicalTrials.gov registry record · Phase 3
Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
NCT00001937: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00001937 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 800 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001937, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 800 participants
- Enrollment target
Study 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.
Interventions
- DRUG Fluconazole
- DRUG FK463
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 1999-11 |
| Est. Completion | 2000-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001937
The ClinicalTrials.gov registry entry for NCT00001937 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fluconazole is the first listed.
NCT00001937 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001937 about?
NCT00001937 is a clinical study titled "Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients". 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 f...
What is the current status of trial NCT00001937?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 1999-11. Estimated completion is 2000-12.
What interventions are being tested in trial NCT00001937?
The interventions under investigation include: Fluconazole (DRUG), FK463 (DRUG).
Who is sponsoring clinical trial NCT00001937?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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