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NCT00058682 · ClinicalTrials.gov registry record · Phase 3
Anidulafungin Versus Fluconazole in the Treatment of Candidemia
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 248
- Enrollment target
NCT00058682: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00058682 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 248 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00058682, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 248 participants
- Enrollment target
Study Summary
Fluconazole is an FDA-approved drug that is widely used to treat fungal infections due to candida. The experimental drug anidulafungin has been found to be active in treating life-threatening fungal infections. The purpose of this study is to determine whether anidulafungin is as effective as fluconazole in treating candidemia, an invasive form of candidiasis. Three hundred patients 16 years of age or older will participate in this study. Participants will be randomly assigned to one of two groups: one-half will receive anidulafungin; the other half will receive fluconazole. They will receive the drug for as few as 10 days or for up to 42 days, depending on the seriousness of the infection. The drug will be given over a four-hour period on the first day, and over two hours on the remaining days. While taking the study medication, participants will be required to give blood samples every week until the end of treatment. At two weeks and six weeks following the end of therapy, participants will return for evaluation. Prior to their participation in this study, patients will undergo the following evaluations: a physical exam, an eye exam, an electrocardiogram, and possibly blood work.
Interventions
- DRUG Anidulafungin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2003-04 |
| Est. Completion | 2005-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00058682
The ClinicalTrials.gov registry entry for NCT00058682 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Anidulafungin is the first listed.
NCT00058682 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00058682 about?
NCT00058682 is a clinical study titled "Anidulafungin Versus Fluconazole in the Treatment of Candidemia". Fluconazole is an FDA-approved drug that is widely used to treat fungal infections due to candida. The experimental drug anidulafungin has been found to be active in treating life-threatening fungal infections. The purpose of this study is to determine whether anidulafungin is as effective as flucon...
What is the current status of trial NCT00058682?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 248 participants. The study started on 2003-04. Estimated completion is 2005-01.
What interventions are being tested in trial NCT00058682?
The interventions under investigation include: Anidulafungin (DRUG).
Who is sponsoring clinical trial NCT00058682?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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