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NCT00815516 · ClinicalTrials.gov registry record · Phase 3
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT00815516: Clinical Trial Phase 3 study, sponsored by Astellas Pharma Global Development.
NCT00815516 is a Phase 3 study that was terminated before completion, run by Astellas Pharma Global Development. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00815516, a Phase 3 study, was terminated before completion, sponsored by Astellas Pharma Global Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.
Primary Outcome
Fungal-free survival was assessed by an independent data review panel (DRP). Fungal-free survival is defined as the percentage of participants alive at one week following the last dose of study drug with a mycological response of eradication and no requirement for alternative systemic antifungal therapy for continued treatment. Eradication was defined as culture or histologically documented absence of the infecting Candida species from all positive normally sterile sites during therapy, documen
Interventions
- DRUG micafungin
- DRUG amphotericin B deoxycholate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
Why NCT00815516 stopped before completion
NCT00815516 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which micafungin is the first listed.
NCT00815516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00815516 about?
NCT00815516 is a clinical study titled "Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis". The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.
What is the current status of trial NCT00815516?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2013-02. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00815516?
The interventions under investigation include: micafungin (DRUG), amphotericin B deoxycholate (DRUG).
Who is sponsoring clinical trial NCT00815516?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00815516's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 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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