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Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

Last updated on May 10, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Aspergillosis, Invasive Pulmonary Aspergillosis, Neuroaspergillosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of proven, probable, or possible invasive aspergillosis.

- Hematologic malignancy or allogeneic hematopoetic stem cell transplant.

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

- Sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis.

- Chronic invasive aspergillosis.

- Receipt of antifungal treatment for more than 96 hours.

- Severe liver dysfunction.

NCT01188759
Pfizer
Withdrawn
Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

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Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Aspergillosis
  • Invasive Pulmonary Aspergillosis
  • Neuroaspergillosis
  • 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.

  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2014
August 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Egypt,   United States
 
NCT01188759
A1501095
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the

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

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