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The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients with Invasive Candidiasis.



The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients with Invasive Candidiasis.

For Condition: Candidiasis
Status: Completed
Sponsor(s): Vicuron Pharmaceuticals ,
Synopsis: Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Positive culture plus at least one clinical sign and symptom consistent with invasive candidiasis preferably within 96 hours of the proposed first dose of study drug - Life expectancy: greater than 72 hours Exclusion Criteria: - Pregnant Females - Treatment with other investigational drug(s) within 4 weeks - Hypersensitivity to anidulafungin or echinocandin therapy - Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
Total Enrollment: 

Location and Contact Information:

Versicor, Inc.
King Of Prussia,  Pennsylvania,  19406
United States
 


Additional Information:
Study ID Numbers:
  VER002-6; 
Study Start Date: June 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037219

Other Candidiasis Studies:
1. The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients with Invasive Candidiasis.

2. Caspofungin for the Treatment of Non-blood Candida Infections

3. Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients

4. The Safety and Efficacy of Intravenous Anidulafungin as a Treatment for Azole-Refractory Mucosal Candidiasis (FRMC)

5. Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants

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The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients with Invasive Candidiasis.

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