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NCT01307579 · ClinicalTrials.gov registry record · Phase 3
Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 517
- Enrollment target
NCT01307579 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 517 participants.
The verdict
NCT01307579, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 517 participants
- Enrollment target
Study Summary
This randomized phase III trial compares the effectiveness of caspofungin to fluconazole in preventing invasive fungal infections in patients receiving chemotherapy for acute myeloid leukemia (AML). Antifungal prophylaxis is considered standard of care in children and adults with prolonged neutropenia after chemotherapy for AML however the ideal antifungal agent for prophylaxis in children is not known. Caspofungin has activity against yeast and some molds while fluconazole coverage is limited to just yeasts. Adult randomized trials suggest that agents with activity against yeasts and molds are more effective than those with just activity against yeasts. There are limited data to answer this comparative question in children. This study will establish much needed pediatric data to guide clinical decision making on optimal antifungal prophylaxis.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Fluconazole
- DRUG Caspofungin Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 517 participants |
| Start Date | 2011-04-04 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01307579
The ClinicalTrials.gov registry entry for NCT01307579 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 517 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01307579 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01307579 about?
NCT01307579 is a clinical study titled "Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia". This randomized phase III trial compares the effectiveness of caspofungin to fluconazole in preventing invasive fungal infections in patients receiving chemotherapy for acute myeloid leukemia (AML). Antifungal prophylaxis is considered standard of care in children and adults with prolonged neutropen...
What is the current status of trial NCT01307579?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 517 participants. The study started on 2011-04-04. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT01307579?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Fluconazole (DRUG), Caspofungin Acetate (DRUG).
Who is sponsoring clinical trial NCT01307579?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
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