Conditions: Candidiasis Candidemia
Keywords: Open-Label Pharmacokinetics Intravenous to oral switch Safety Voriconazole Immunocompromise Children High Risk For Systemic Fungal Infection.
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief 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 12 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.

Detailed description:

Arms:
arm 1: Immunocompromised children aged 2 to \<12 years who are at high risk for systemic fungal infection.

Interventions: intervention 1: voriconazole (Vfend)
Intervention descriptions: intervention 1: Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h

Notes:

1. 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.
2. 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)

Protocol document: