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NCT01200355 · ClinicalTrials.gov registry record · Phase 4
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
A Phase 4 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 113
- Enrollment target
NCT01200355: Completed Phase 4 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01200355 is a Phase 4 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 113 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01200355, a Phase 4 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 113 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effects, good and/or bad, of posaconazole and micafungin in preventing fungal infections after chemotherapy for acute leukemia or myelodysplastic syndrome. When people take chemotherapy, they are more likely to get infections. Posaconazole has been approved for the prevention of fungal infections in patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome. Posaconazole is available only as an oral suspension and has to be given with food. After chemotherapy, many patients are not able to tolerate food or oral medication because of severe mucositis. Patients unable to tolerate food and oral medications cannot take posaconazole. Micafungin is an antifungal medication that is given only intravenously. Micafungin is approved for the treatment of certain fungal infections and for preventing fungal infections in patients who receive bone marrow transplant. The investigators know that micafungin is safe. Micafungin has not been tested for the prevention of fungal infections in patients receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin is given by vein, it can be given even in patients who cannot take food or medications by mouth after chemotherapy. In this study the investigators want to compare micafungin to posaconazole when given for the prevention of fungal infections in leukemia and myelodysplastic syndrome patients.
Interventions
- DRUG micafungin
- DRUG posaconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2010-09-09 |
| Est. Completion | 2018-04-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01200355
The ClinicalTrials.gov registry entry for NCT01200355 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which micafungin is the first listed.
NCT01200355 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01200355 about?
NCT01200355 is a clinical study titled "Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome". The purpose of this study is to compare the effects, good and/or bad, of posaconazole and micafungin in preventing fungal infections after chemotherapy for acute leukemia or myelodysplastic syndrome. When people take chemotherapy, they are more likely to get infections. Posaconazole has been approve...
What is the current status of trial NCT01200355?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 113 participants. The study started on 2010-09-09. Estimated completion is 2018-04-03.
What interventions are being tested in trial NCT01200355?
The interventions under investigation include: micafungin (DRUG), posaconazole (DRUG).
Who is sponsoring clinical trial NCT01200355?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
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