NCT00056368

Brief Summary

Anidulafungin is a medicine being developed for treatment of patients with certain kinds of fungal infections. These infections due to yeast (a type of fungus) in the mouth/esophagus, in the blood or in other areas within the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2003

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2003

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

First QC Date

March 11, 2003

Last Update Submit

October 17, 2008

Conditions

Candidiasis

Keywords

Candida blood stream infectionsCandida infectionsCandidemiaInvasive Candidiasis

Interventions

AnidulafunginDRUG
FluconazoleDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Diagnosis of candidemia and/or other forms of invasive candidiasis. * Should not have received greater than 48 hours of systemic antifungal therapy. * Life expectancy should be greater than 72 hours. * Should not have received greater than one week of prophylactic azole therapy 30 days prior to enrollment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Versicor, Inc.

King of Prussia, Pennsylvania, 19406, United States

Location

Related Publications (1)

  • Reboli AC, Rotstein C, Pappas PG, Chapman SW, Kett DH, Kumar D, Betts R, Wible M, Goldstein BP, Schranz J, Krause DS, Walsh TJ; Anidulafungin Study Group. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007 Jun 14;356(24):2472-82. doi: 10.1056/NEJMoa066906.

    PMID: 17568028DERIVED

MeSH Terms

Conditions

CandidiasisCandidemiaCandidiasis, Invasive

Interventions

AnidulafunginFluconazole

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EchinocandinsPeptides, CyclicPeptidesAmino Acids, Peptides, and ProteinsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2003

First Posted

March 12, 2003

Study Start

March 1, 2003

Study Completion

October 1, 2004

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

US(1)