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Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

Last updated on November 10, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Aspergillosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00531479
Pfizer
Completed
Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis

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Descriptive Information
Brief Title  ICMJE Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
Official Title  ICMJE 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
Brief SummaryThis 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aspergillosis
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  ICMJE
  • Active Comparator: Voriconazole
    Voriconazole monotherapy
    Intervention: Drug: voriconazole
  • Experimental: Voriconazole and Anidulafungin
    Combination therapy with voriconazole and anidulafungin
    Interventions:
    • Drug: anidulafungin
    • Drug: voriconazole
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2012)
459
Original Enrollment  ICMJE
 (submitted: September 14, 2007)
335
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion DateApril 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Greece,   India,   Italy,   Korea, Republic of,   Netherlands,   Peru,   Poland,   Portugal,   Russian Federation,   Singapore,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Removed Location CountriesAustria,   Saudi Arabia
 
Administrative Information
NCT Number  ICMJE NCT00531479
Other Study ID Numbers  ICMJE A8851009
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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