Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis


Tracking Information

Start Date  ICMJEMay 2008
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: January 23, 2008)
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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: September 14, 2007)
The primary endpoint is all cause mortality, measured 6 weeks after IA diagnosis in subjects with proven or probable IA.
Change HistoryComplete list of historical versions of study NCT00531479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: May 6, 2008)
  • Rate of global response at 6 weeks [ Time Frame: at 6 weeks ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Safety and tolerability of voriconazole monotherapy compared to that of voriconazole in combination with anidulafungin [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
  • All cause mortality at 12 weeks in subjects with probable or proven IA [ Time Frame: All cause mortality at 12 weeks ] [ Designated as safety issue: No ]
  • Mortality due to IA at 6 weeks [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]
  • Time to death (all cause mortality) [ Time Frame: Time to death (all cause mortality) ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: September 14, 2007)
  • Rate of global response at 6 weeks
  • All cause mortality at 12 weeks
  • Time to death (all cause mortality)

Descriptive Information

Brief Title  ICMJEAnidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
Official Title  ICMJEA 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
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEAspergillosis
Intervention  ICMJE
  • 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.

    Other Name: Vfend
  • 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.

    Other Name: Eraxis
  • 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.

    Other Name: Vfend
Study Arms / Comparison Groups
  • Voriconazole: Active Comparator
    Voriconazole monotherapy
    Intervention: Drug: voriconazole
  • Voriconazole and Anidulafungin: Experimental
    Combination therapy with voriconazole and anidulafungin
    Interventions:
    • Drug: anidulafungin
    • Drug: voriconazole

Recruitment Information

Estimated Enrollment  ICMJE405
Estimated Completion DateSeptember 2011
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages16 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Greece,   India,   Italy,   Korea, Republic of,   Netherlands,   Peru,   Poland,   Portugal,   Russian Federation,   Saudi Arabia,   Singapore,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00531479
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA8851009
Study Sponsor  ICMJEPfizer
Collaborators  ICMJEMycoses Study Group
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer