The Safety and Effectiveness of Intravenous Anidulafungin... | NCT00037219

Studies
The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.

NCT00037219

Sponsor

Pfizer

Status

Completed

Last Update Posted

Oct 21, 2008Estimated

Enrollment

120Actual

Phase

Phase 2

Conditions

Candidiasis

Interventions

Anidulafungin, VER002

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
A8851018

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2001

Primary Completion Date

Not provided

Completion Date

Nov 2002Actual

First Submitted Date

May 16, 2002

First Submission Date that Met QC Criteria

May 16, 2002

First Posted Date

May 17, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2008

Last Update Posted Date

Oct 21, 2008Estimated

Name	Class
Vicuron Pharmaceuticals	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Name	Type	Description	Arm Group Labels	Other Names
Anidulafungin, VER002	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Versicor, Inc.		King of Prussia	Pennsylvania	19406	United States

Condition Browse Module

MeSH Terms

ID	Term
D002177	Candidiasis
D058387	Candidemia
D058365	Candidiasis, Invasive

Ancestor Terms

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000072742	Invasive Fungal Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077612	Anidulafungin

Ancestor Terms

ID	Term
D054714	Echinocandins
D010456	Peptides, Cyclic
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided