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

Aspergillosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037206
• Other study ID #: VER002-7
• Secondary ID: A8851001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 16, 2002
• Last updated: October 17, 2008
• Start date: May 2002
• Est. completion date: February 2003

Study information

• Verified date: October 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis

Intervention

Drug:
• Anidulafungin, VER002

Locations

Country	Name	City	State
United States	Versicor, Inc.	King of Prussia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Vicuron Pharmaceuticals

Country where clinical trial is conducted

United States,