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NCT00413218 · ClinicalTrials.gov registry record · Phase 3
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
A Phase 3 study of Candidemia and Mycoses, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT00413218: Completed Phase 3 study of Candidemia and Mycoses, sponsored by Astellas Pharma.
NCT00413218 is a Phase 3 study of Candidemia and Mycoses that has completed, run by Astellas Pharma. The registered enrollment target is 450 participants, above the 358-participant average among 8 other Candidemia trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00413218, a Phase 3 study of Candidemia and Mycoses, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.
Primary Outcome
A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.
Conditions Studied
Interventions
- DRUG Caspofungin
- DRUG Isavuconazole
- DRUG Voriconazole
Study Locations (20)
California
- Somero Research Corporation - Palm Desert
- University of California Davis Health System - Sacramento
- University of California at San Francisco - San Francisco
Illinois
- Loyola University Hospital - Maywood
- Springfield Clinic LLP - Springfield
Other
- Hospital Britanico de Buenos Aires - Capital Federal
- Hospital General de Agudos Dr. Carlos G. Durand - Capital Federal
Alabama
- University of Alabama at Birmingham - Birmingham
Idaho
- Idaho Falls Infectious Diseases PLLC - Idaho Falls
Indiana
- Infectious Disease of Indiana - Indianapolis
Louisiana
- Ochsner Clinic Foundation - New Orleans
Maryland
- University of Maryland School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2007-03-08 |
| Est. Completion | 2015-03-03 |
| Phase | Phase 3 |
What the finished NCT00413218 record still lists
NCT00413218 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 358-participant average among 8 other Candidemia trials with a reported enrollment target (26% higher).
The record links to 3 conditions, with Candidemia appearing as the primary indexed condition, and to 3 interventions - of which Caspofungin is the first listed.
NCT00413218 names 20 study sites across 16 states, led by California, Illinois, Other.
Frequently Asked Questions
What is clinical trial NCT00413218 about?
NCT00413218 is a clinical study titled "Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections". The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.
What is the current status of trial NCT00413218?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2007-03-08. Estimated completion is 2015-03-03.
What conditions does trial NCT00413218 study?
This clinical trial studies the following conditions: Candidemia, Mycoses, Candidiasis, Invasive.
What interventions are being tested in trial NCT00413218?
The interventions under investigation include: Caspofungin (DRUG), Isavuconazole (DRUG), Voriconazole (DRUG).
Who is sponsoring clinical trial NCT00413218?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00413218 being conducted?
This trial has 20 study locations across Alabama, California, Idaho, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Candidemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00413218's enrollment target sits among peer trials
450 4th of 8 higher than 4 of 8 other Candidemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Candidemia 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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