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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 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 282 participants.

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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.

Interventions

  • DRUG Eraxis (anidulafungin)
  • DRUG Diflucan (fluconazole)
  • DRUG Vfend (voriconazole)

Trial Details

FieldValue
Enrollment Target 282 participants
Start Date 2007-07
Est. Completion 2010-06
Phase Phase 4

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT00496197

The ClinicalTrials.gov registry entry for NCT00496197 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 282 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Eraxis (anidulafungin) is the first listed.

NCT00496197 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.