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NCT01503515 · ClinicalTrials.gov registry record · Phase 3
Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 292
- Enrollment target
NCT01503515: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT01503515 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 292 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01503515, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 292 participants
- Enrollment target
Study Summary
This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant.
Primary Outcome
Kaplan-Meier curves will be used to estimate the 42- day-cumulative incidence of proven/probable IFI following allogeneic HCT for patients randomized to the 2 arms. Proven or probable IFI is defined according to criteria developed by the European Organization for Research and Treatment of Cancer (EORTC)/Mycoses Study Group (MSG).
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Fluconazole
- DRUG Voriconazole
- DRUG Caspofungin Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2013-03-21 |
| Est. Completion | 2021-09-30 |
| Phase | Phase 3 |
What the finished NCT01503515 record still lists
NCT01503515 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01503515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01503515 about?
NCT01503515 is a clinical study titled "Caspofungin Acetate, Fluconazole, or Voriconazole in Preventing Fungal Infections in Patients Following Donor Stem Cell Transplant". This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in ...
What is the current status of trial NCT01503515?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 292 participants. The study started on 2013-03-21. Estimated completion is 2021-09-30.
What interventions are being tested in trial NCT01503515?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Fluconazole (DRUG), Voriconazole (DRUG), Caspofungin Acetate (DRUG).
Who is sponsoring clinical trial NCT01503515?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01503515's enrollment target sits among peer trials
292 1166th of 2000 higher than 833 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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