A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA).

This study has been completed.

First Received on May 16, 2002. Last Updated on October 17, 2008 History of Changes

Sponsor:	Pfizer
Collaborator:	Vicuron Pharmaceuticals
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00037206

Purpose

The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated patients located in the United States, Europe, and South Africa.

Condition	Intervention	Phase
Aspergillosis	Drug: Anidulafungin, VER002	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label Non-Comparative Study of the Safety and Efficacy of Intravenous Anidulafungin Plus AmBisome® [(Amphotericin B) Liposome for Injection] as a Treatment for Invasive Aspergillosis.

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis

Drug Information available for: Amphotericin B Anidulafungin Liposomal Amphotericin B

U.S. FDA Resources

Further study details as provided by Pfizer:

Enrollment:	30
Study Start Date:	May 2002
Study Completion Date:	February 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of definite IA outside the pulmonary system or definite or probable pulmonary IA
Life expectancy: greater than 72 hours

Exclusion Criteria:

Pregnant female
Hypersensitivity to anidulafungin or echinocandin therapy
Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
Hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome unless, in the opinion of the investigator, the benefit of therapy outweighs the risk.
Aspergilloma-in the absence of invasive disease
Abnormal blood chemistries:

Bilirubin > 3 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase)> 5 times the upper limit of normal

Greater than five days of therapeutic doses of systemic therapy for the current Aspergillus-associated condition or a cumulative dose of more than 5 mg/Kg of amphotericin, more than 25 mg/Kg of a lipid formulation of amphotericin, or more than 2g of itraconazole for the current condition. Prophylactic use of azoles or amphotericin is acceptable.
Less than 4 weeks since prior participation in an investigational drug or device study, with the exception of cytotoxic, antiretroviral agents and therapies for AIDS-related opportunistic infections.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037206

Locations

United States, Pennsylvania
Versicor, Inc.
King of Prussia, Pennsylvania, United States, 19406

Sponsors and Collaborators

Pfizer

Vicuron Pharmaceuticals

More Information

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00037206 History of Changes
Other Study ID Numbers:	VER002-7, A8851001
Study First Received:	May 16, 2002
Last Updated:	October 17, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Invasive Aspergillosis

Additional relevant MeSH terms:

Aspergillosis
Mycoses
Liposomal amphotericin B
Anidulafungin
Echinocandins
Antiprotozoal Agents

Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents

ClinicalTrials.gov processed this record on May 21, 2012