NCT00037219

Brief Summary

Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2001

Shorter than P25 for phase_2

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

August 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2002

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

First QC Date

May 16, 2002

Last Update Submit

October 17, 2008

Conditions

Candidiasis

Keywords

AnidulafunginCandidemiaInvasive Candidiasis

Interventions

Anidulafungin, VER002DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive culture plus at least one clinical sign and symptom consistent with invasive candidiasis preferably within 96 hours of the proposed first dose of study drug
  • Life expectancy: greater than 72 hours

You may not qualify if:

  • Pregnant Females
  • Treatment with other investigational drug(s) within 4 weeks
  • Hypersensitivity to anidulafungin or echinocandin therapy
  • Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid

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

CandidiasisCandidemiaCandidiasis, Invasive

Interventions

Anidulafungin

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 Proteins

Study Design

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

Study Record Dates

First Submitted

May 16, 2002

First Posted

May 17, 2002

Study Start

August 1, 2001

Study Completion

November 1, 2002

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

US(1)