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

NCT ID: NCT00037206

Last Updated: 2008-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2003-02-28

Brief Summary

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.

Conditions

Aspergillosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Anidulafungin, VER002

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vicuron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Pfizer, Inc.

Locations

Versicor, Inc.

King of Prussia, Pennsylvania, United States

Countries

United States

Other Identifiers

A8851001

Identifier Type: -

Identifier Source: secondary_id

VER002-7

Identifier Type: -

Identifier Source: org_study_id