NCT00041704

Brief Summary

Anidulafungin is an antifungal agent of the echinocandin class which is highly active in vitro against fluconazole resistant Candida species. The efficacy of anidulafungin has demonstrated in various animal models of fluconazole-resistant mucosal disease; as well as, in Phase 2 Esophageal Candidiasis studies. This study is intended to offer patients with FRMC an alternate therapy with amphotericin B or with other agents whose efficacy and/or safety are inadequate in the treatment of this disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2002

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2002

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

October 20, 2008

Status Verified

October 1, 2008

First QC Date

July 12, 2002

Last Update Submit

October 17, 2008

Conditions

Candidiasis

Keywords

Azole-Refractory Mucosal CandidiasisMucosal Candidiasis

Interventions

Anidulafungin, VER002DRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of definite azole-refractory mucosal candidiasis (oral or oropharyngeal candidiasis or esophageal candidiasis), i.e., patients who have not responded to a prior 14-day course of fluconazole at a dose of at least 200 mg daily or other azole (e.g. voriconazole)
  • Grade 1 or higher mucosal disease and microscopic or culture confirmation of yeast

You may not qualify if:

  • Pregnant female
  • Hypersensitivity to anidulafungin or echinocandin therapy
  • Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
  • Abnormal blood chemistries: Bilirubin \>2 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \> 4 times the upper limit of normal
  • Less than four weeks since prior participation in an investigational drug or device study with the exception of antiretroviral agents or licensed agents
  • Patients taking other systemic antifungal therapies while on this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Versicor, Inc.

King of Prussia, Pennsylvania, 19406, United States

Location

MeSH Terms

Conditions

Candidiasis

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

EchinocandinsPeptides, CyclicPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 12, 2002

First Posted

July 16, 2002

Study Start

August 1, 2002

Study Completion

August 1, 2004

Last Updated

October 20, 2008

Record last verified: 2008-10

Locations

US(1)