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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
Est. primary completion date
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


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, 

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