Voriconazole And Anidulafungin Combination For Invasive Aspergillosis In Pediatric Subjects

• 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

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.