Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis
Condition: Candidiasis
MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive
Intervention: Eraxis (anidulafungin); Diflucan (fluconazole); Vfend (voriconazole)
Intervention description: Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.; Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis.; Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.
Intervention MeSH terms: Fluconazole; Voriconazole; Anidulafungin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: candidemia; invasive candidiasis; fungal bloodstream infection

Summary:

      The purpose of this study is to further evaluate the safety and effectiveness of intravenous
      anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis,
      which is a fungus infection of the blood or tissue. Currently the drug is approved for
      treatment using a daily dose of IV medication until 14 days after the fungus disappears from
      the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is
      administered for 5-28 days followed by oral antifungal medication. Study patients will be
      assessed for response to treatment throughout the study drug treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects > or equal to 18 years of age.

          -  Presence of candidemia (positive blood culture) or invasive candidiasis
             (histopathologic or cytopathologic examination of a needle aspiration or biopsy
             specimen from a normally sterile site excluding mucous membranes showing yeast cells)
             obtained within the prior 96 hours of the screening visit.

          -  Subjects who received no more than one prior dose of an echinocandin or polyene.

        Exclusion Criteria:

          -  Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.

          -  Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.

          -  Subjects with infected prosthetic devices which cannot be removed within 24 hours