Anidulafungin Versus Fluconazole in the Treatment of Candidemia
Public ClinicalTrials.gov record NCT00058682. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Double Blind, Randomized, Multi-Center Study of the Safety and Efficacy of Anidulafungin VS. Fluconazole in the Treatment of Patients With Candidemia and Other Forms of Invasive Candidiasis and Prevention of Complications
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00058682
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 248 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2003
- Primary completion
- Not listed
- Completion
- Dec 31, 2004
- Last update posted
- Mar 3, 2008
2003 – 2005
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Cancer Institute (NCI) | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00058682, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 3, 2008 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00058682 live on ClinicalTrials.gov.