FOCUS (all cancer types)
Recruiting
Who can enter
Children receiving fluconazole to prevent or treat an invasive fungal infection
Children aged 2-18 years
Goal
Goal
The goal of this study is to optimize fluconazole dosing in children for the prevention or treatment of invasive fungal infections.
Background
Background
Immunocompromised children, such as children with cancer or certain auto-immune deficiencies, have an increased risk for severe fungal infections. Mortality rates under these children are extremely high. Of all children with an invasive fungal infection, 20-80% dies because of the consequences of this infection.
Fluconazole is an important drug to prevent and treat these fungal infections. Although fluconazole has been available since 1990, little information is known on its use in children. Information on the dose needed to treat children best is lacking. The current fluconazole dose for children is derived from the adult dosing regimen and adjusted for the child’s body weight. This may sound reasonable, but children are not small adults. Their bodies are developing and a drug is handled differently than by an adult body. That is why children sometimes need higher or lower doses of a drug. The wrong dose can result in an ineffective therapy or in more adverse side effects.
With this study, we want to investigate what fluconazole dose is exactly needed to treat a child effectively and safely. It is our goal to ensure that this dosing regimen will be implemented in international guidelines, so all physicians can prescribe the best dose for a child.
In order to participate in a study please refer to your/your child’s doctor.
Last reviewed
Last reviewed
March 20, 2026
Study details
- Study details
Official title
Pharmacokinetics of fluconazole given orally or intravenously as prophylaxis or therapy to children and adolescents with invasive fungal infectionsCancer type
All typesMaximum number of patients
30, of whom approximately 15 are expected to participate in the NetherlandsStart date
May 10, 2023Status
OpenLocal principal investigator
Prof. dr. L.J. BontSponsor
Radboud university medical center, NijmegenApproval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.Trial registry number
ClinialTrials.gov NCT05130723
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.