The Safety and Efficacy of Anidulafungin Versus Comparato... | NCT00056368

Studies
The Safety and Efficacy of Anidulafungin Versus Comparator in Patients With Candidemia and Invasive Candidiasis

NCT00056368

Sponsor

Pfizer

Status

Completed

Last Update Posted

Oct 21, 2008Estimated

Enrollment

256Actual

Phase

Phase 3

Conditions

Candidiasis

Interventions

Anidulafungin
Fluconazole

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
A8851002

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

Not provided

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Oct 2004Actual

First Submitted Date

Mar 11, 2003

First Submission Date that Met QC Criteria

Mar 11, 2003

First Posted Date

Mar 12, 2003Estimated

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 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.

Detailed Description

Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

256Actual

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17568028	Derived	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.

ID	Term
D002177	Candidiasis
D058387	Candidemia
D058365	Candidiasis, Invasive

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

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

Name	Type	Description	Arm Group Labels	Other Names
Anidulafungin	Drug
Fluconazole	Drug

ID	Term
D000077612	Anidulafungin
D015725	Fluconazole