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

Pfizer

Status and phase

Completed

Phase 3

Phase 2

Conditions

Aspergillosis

Treatments

Drug: Anidulafungin, VER002

Study type

Interventional

Funder types

Industry

Identifiers

NCT00037206

VER002-7

A8851001

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.