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Trial record 1 of 1 for:    NCT01188759
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Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

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ClinicalTrials.gov Identifier: NCT01188759
Recruitment Status : Withdrawn
First Posted : August 25, 2010
Last Update Posted : May 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 24, 2010
First Posted Date  ICMJE August 25, 2010
Last Update Posted Date May 11, 2012
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
Safety and tolerability of voriconazole and anidulafungin in combination versus voriconazole alone as determined by rates of adverse events [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
  • Rate of all-cause mortality at 6 weeks [ Time Frame: 6 weeks ]
  • Rate of all-cause mortality at EOT [ Time Frame: 12 weeks ]
  • Global response to therapy at 6 weeks [ Time Frame: 6 weeks ]
  • Global response to therapy at EOT [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aspergillosis
  • Invasive Pulmonary Aspergillosis
  • Neuroaspergillosis
Intervention  ICMJE
  • Drug: Voriconazole

    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.

  • Drug: Anidulafungin

    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.

Study Arms  ICMJE
  • Experimental: Voriconazole and Anidulafungin Combination
    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.
    Interventions:
    • Drug: Voriconazole
    • Drug: Anidulafungin
  • Active Comparator: Voriconazole Monotherapy
    Subjects in the monotherapy arm will receive voriconazole monotherapy for 6-12 weeks of therapy.
    Intervention: Drug: Voriconazole
Publications * Not Provided

*   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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 10, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2010)
60
Estimated Study Completion Date  ICMJE August 2014
Estimated Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Egypt,   United States
 
Administrative Information
NCT Number  ICMJE NCT01188759
Other Study ID Numbers  ICMJE A1501095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP