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

Last updated on March 14, 2019

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Study Location
Versicor, Inc.
King of Prussia, Pennsylvania, 19406 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Aspergillosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Diagnosis of definite IA outside the pulmonary system or definite or probable
pulmonary IA

- Life expectancy: greater than 72 hours

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00037206
Pfizer
Completed
A Safety & Effectiveness Study of Intravenous Anidulafungin With AmBisome® for Treatment of Invasive Aspergillosis (IA).

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