Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

Official Title: “A Prospective, Randomized Trial Comparing The Efficacy Of Anidulafungin And Voriconazole In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Proven Or Probable Invasive Aspergillosis”

This study compares the effectiveness and safety of the combination of anidulafungin and voriconazole compared to that of voriconazole alone (which is generally considered the standard of care) for the treatment of Invasive Aspergillosis.

Intervention(s) in this Clinical Trial

• Drug: voriconazole
  • First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
• Drug: anidulafungin
  • First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
• Drug: voriconazole
  • First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter. Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd. Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd, OR Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy. Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Voriconazole
  • Voriconazole monotherapy
• Experimental: Voriconazole and Anidulafungin
  • Combination therapy with voriconazole and anidulafungin

Primary Measures

• The primary endpoint is all cause mortality, measured 6 weeks after IA initiation of study drug in subjects with proven or probable IA.
  • Time Frame: 6 weeks after IA initiation
    Safety Issue?: No

Secondary Measures

• Rate of global response at 6 weeks
  • Time Frame: at 6 weeks
    Safety Issue?: No
• All cause mortality at 6 weeks in subjects with possible, probable, or proven IA
  • Time Frame: All cause mortality at 6 weeks
    Safety Issue?: No
• Safety and tolerability of voriconazole monotherapy compared to that of voriconazole in combination with anidulafungin
  • Time Frame: Duration of trial
    Safety Issue?: No
• All cause mortality at 12 weeks in subjects with probable or proven IA
  • Time Frame: All cause mortality at 12 weeks
    Safety Issue?: No
• Mortality due to IA at 6 weeks
  • Time Frame: at 6 weeks
    Safety Issue?: No
• Time to death (all cause mortality)
  • Time Frame: Time to death (all cause mortality)
    Safety Issue?: No

Inclusion Criteria:

• Immunocompromised state due to either 1. receipt of hematopoeitic stem cell transplantation or 2. hematologic malignancy;
• Diagnosis of possible, probable, or proven invasive aspergillosis.

Exclusion Criteria:

• Patients with aspergilloma or chronic aspergillosis
• Receipt of 4 or more days of systemic antifungal treatment for the current episode of invasive aspergillosis
• Anticipated survival of less than 5 days or Karnofsky score <=20

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00531479

Study ID Number: A8851009

ClinicalTrials.gov Identifier: NCT00531479

Health Authority: United States: Food and Drug Administration

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