Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection
Condition: Aspergillosis, Aspergilloma
MeSH terms: Infections; Mycoses; Aspergillosis
Intervention: Voriconazole; Voriconazole
Intervention description: Study Days 1: IV voriconazole 9 mg/kg q12h. Study Days 2 to 7: IV voriconazole 8 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 9 mg/kg q12h with a maximum of 350 mg q12 h.
Notes:
If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.
(IV = Intravenous; POS = Powder for oral suspension); Study Days 1: IV voriconazole 6 mg/kg q12h. Study Days 2 to 7: IV voriconazole 4 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h.
Notes:
If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.
(IV = Intravenous; POS = Powder for oral suspension)
Intervention MeSH terms: Voriconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 2 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Open-Label; Pharmacokinetics; Intravenous to oral switch; Safety; Voriconazole; Immunocompromise; Children; High Risk For Systemic Fungal Infection

Summary:

      In this study we will measure the concentration of the drug called voriconazole which is used
      to fight infections caused by fungus in children who usually are cancer patients and have
      their immune system down. Since we know the dose in adults, and we think we know the matching
      doses in the young patients ages 2 to less than 15 years old, we will compare the amount of
      drug that goes into the system with what we know works in adults. We give the drug by a
      needle directly into the blood, then few days later we stop that and give the drug by mouth.
      Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female from 2 to <15 years of age.

          -  Require treatment for the prevention of systemic fungal infection.

          -  Expected to develop neutropenia (ANC <500 cells/uL) lasting more than 10 days
             following chemotherapy.

          -  Anticipated to live for more than 3 months.

        Exclusion Criteria:

          -  Evidence of any clinically significant liver or renal function or other abnormalities
             such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.

          -  Documented bacterial or viral infection not responding to appropriate treatment.

          -  Hypersensitivity to or severe intolerance of azole antifungal agents.

          -  Receiving other azoles or drugs that is are prohibited in the voriconazole label or
             associated.