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NCT00496197 · ClinicalTrials.gov registry record · Phase 4
Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 282
- Enrollment target
NCT00496197: Completed Phase 4 study, sponsored by Pfizer.
NCT00496197 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 282 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00496197, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 282 participants
- Enrollment target
Study Summary
The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.
Primary Outcome
Success: Clinical response=Cure (no signs, symptoms \[s/s\] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up \[f/u\] culture negative) or Presumed Eradication (f/u culture not available \[n/a\] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline
Interventions
- DRUG Eraxis (anidulafungin)
- DRUG Diflucan (fluconazole)
- DRUG Vfend (voriconazole)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
What the finished NCT00496197 record still lists
NCT00496197 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 3 interventions - of which Eraxis (anidulafungin) is the first listed.
NCT00496197 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00496197 about?
NCT00496197 is a clinical study titled "Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis". The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose...
What is the current status of trial NCT00496197?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 282 participants. The study started on 2007-07. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00496197?
The interventions under investigation include: Eraxis (anidulafungin) (DRUG), Diflucan (fluconazole) (DRUG), Vfend (voriconazole) (DRUG).
Who is sponsoring clinical trial NCT00496197?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00496197's enrollment target sits among peer trials
282 303rd of 2000 higher than 1,698 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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