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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Detailed Description

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Conditions

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Aspergillosis

Keywords

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Invasive Aspergillosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Anidulafungin, VER002

Intervention Type DRUG

Eligibility Criteria

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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

Responsible Party

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Pfizer, Inc.

Locations

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Versicor, Inc.

King of Prussia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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A8851001

Identifier Type: -

Identifier Source: secondary_id

VER002-7