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

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ClinicalTrials.gov Identifier: NCT00037206
Recruitment Status : Completed
First Posted : May 17, 2002
Last Update Posted : October 21, 2008
Sponsor:
Collaborator:
Vicuron Pharmaceuticals
Information provided by:
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Aspergillosis Drug: Anidulafungin, VER002 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : May 2002
Actual Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037206


Locations
United States, Pennsylvania
Versicor, Inc.
King of Prussia, Pennsylvania, United States, 19406
Sponsors and Collaborators
Pfizer
Vicuron Pharmaceuticals

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00037206     History of Changes
Other Study ID Numbers: VER002-7
A8851001
First Posted: May 17, 2002    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008

Keywords provided by Pfizer:
Invasive Aspergillosis

Additional relevant MeSH terms:
Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Liposomal amphotericin B
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents