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Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

Primary Purpose

Aspergillosis, Invasive Pulmonary Aspergillosis, Neuroaspergillosis

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Voriconazole
Anidulafungin
Voriconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aspergillosis focused on measuring Aspergillosis, Combination Therapy, Voriconazole, Anidulafungin

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of proven, probable, or possible invasive aspergillosis.
  • Hematologic malignancy or allogeneic hematopoetic stem cell transplant.

Exclusion Criteria:

  • Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
  • Chronic invasive aspergillosis.
  • Receipt of antifungal treatment for more than 96 hours.
  • Severe liver dysfunction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Voriconazole and Anidulafungin Combination

    Voriconazole Monotherapy

    Arm Description

    Subjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy.

    Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.

    Outcomes

    Primary Outcome Measures

    Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events

    Secondary Outcome Measures

    Rate of all-cause mortality at 6 weeks
    Rate of all-cause mortality at EOT
    Global response to therapy at 6 weeks
    Global response to therapy at EOT

    Full Information

    First Posted
    August 24, 2010
    Last Updated
    May 10, 2012
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01188759
    Brief Title
    Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
    Official Title
    A Prospective, Randomized Trial Comparing The Safety, Tolerability, And Efficacy Of Voriconazole And Anidulafungin In Combination To That Of Voriconazole Alone When Used For Primary Therapy Of Invasive Aspergillosis in Pediatric Subjects Aged 2 to 17 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    August 2014 (Anticipated)
    Study Completion Date
    August 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to compare the safety, tolerability, and efficacy of voriconazole and anidulafungin in combination versus voriconazole alone in pediatric subjects aged 2 to 17 years with invasive aspergillosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aspergillosis, Invasive Pulmonary Aspergillosis, Neuroaspergillosis
    Keywords
    Aspergillosis, Combination Therapy, Voriconazole, Anidulafungin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Voriconazole and Anidulafungin Combination
    Arm Type
    Experimental
    Arm Description
    Subjects in the combination arm will receive voriconazole and anidulafungin in combination for 2-4 weeks followed by voriconazole monotherapy to complete 6-12 weeks of therapy.
    Arm Title
    Voriconazole Monotherapy
    Arm Type
    Active Comparator
    Arm Description
    Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Voriconazole
    Intervention Description
    For Children aged 2-11 years and adolescents aged 12-14 years weighing <50 kg: Voriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days. For adolescents aged 12-17 years, excluding 12-14-year-olds weighing <50kg: Voriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days. Voriconazole therapy is to be given for 6-12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Anidulafungin
    Intervention Description
    Anidulafungin 3 mg/kg IV load q24h x 24h (maximum 200 mg), then 1.5 mg/kg q24h (maximum 100 mg). Anidulafungin therapy is to be given for 2-4 weeks in combination with voriconazole.
    Intervention Type
    Drug
    Intervention Name(s)
    Voriconazole
    Intervention Description
    For Children aged 2-11 years and adolescents aged 12-14 years weighing <50 kg: Voriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days. For adolescents aged 12-17 years, excluding 12-14-year-olds weighing <50kg: Voriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days. Voriconazole therapy is to be given for 6-12 weeks.
    Primary Outcome Measure Information:
    Title
    Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Rate of all-cause mortality at 6 weeks
    Time Frame
    6 weeks
    Title
    Rate of all-cause mortality at EOT
    Time Frame
    12 weeks
    Title
    Global response to therapy at 6 weeks
    Time Frame
    6 weeks
    Title
    Global response to therapy at EOT
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of proven, probable, or possible invasive aspergillosis. Hematologic malignancy or allogeneic hematopoetic stem cell transplant. Exclusion Criteria: Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis. Chronic invasive aspergillosis. Receipt of antifungal treatment for more than 96 hours. Severe liver dysfunction.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501095&StudyName=Voriconazole%20And%20Anidulafungin%20Combination%20For%20Invasive%20Aspergillosis%20In%20Pediatric%20Subjects
    Description
    To obtain contact information for a study center near you, click here.

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    Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

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