Clinical trial • Phase IV • Infectious Disease

Fluconazole for Invasive fungal infection

Phase IV trial of Fluconazole for Invasive fungal infection. 30 participants.

Overview

Phase IV trial across 2 sites in Netherlands.

Recruits 30 paediatric patients.

Vulnerable Population: Children and adolescents aged 2-18 years are selected as the vulnerable population (isVulnerablePopulationSelected = true). Age-specific subject information and informed consent forms are provided (documents: L1_SISandICF_adults_parents_..., L1_SISandICF_12-16_..., L1_SISbelow12_...).

{"criterion_text":"- Subject is treated with fluconazole for prophylaxis or treatment of an invasive fungal infection;"}
{"criterion_text":"- Subject is 2 - 18 years of age on the day of the first fluconazole dosing"}
{"criterion_text":"- Subject is managed with a central venous catheter or arterial line from which blood can be obtained"}

{"criterion_text":"- Subject is managed by means of an extracorporeal clearance technique"}
{"criterion_text":"- Subject has previously participated in this study"}

{"endpoint_text":"- The primary objective of this study is to establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years, we aim to describe fluconazole pharmacokinetics in this patient population by means of population pharmacokinetic (pop-PK) modelling. The pharmacokinetic parameters of the developed pop-PK model are among others, clearance (CL), volume of distribution (Vd) and exposure described by the area under the concentration-time curve (AUC).","definition_or_measurement_approach":"Describe fluconazole pharmacokinetics by population pharmacokinetic (pop-PK) modelling. PK parameters include clearance (CL), volume of distribution (Vd) and exposure described by area under the concentration-time curve (AUC)."}

{"endpoint_text":"- Other study parameters are factors that might influence the primary study parameters, the covariates. Since this is an observational study, potential covariates will only be explored. Covariates of interest are renal clearance and body weight. Another study parameter that will be explored is the oral bioavailability (F) of fluconazole, which is the percentage of the drug that is systemically available after oral administration compared to the exposure after intravenous administration.","definition_or_measurement_approach":"Exploratory assessment of covariates (renal clearance and body weight) on PK parameters; exploration of absolute oral bioavailability (F) defined as percentage systemic availability after oral administration compared to exposure after intravenous administration."}

Planned Sample Size: 30
Recruitment Window Months: 42
Consent Approach: Age-specific subject information and informed consent forms are provided (documents listed: L1_SISandICF_adults_parents_PMC; L1_SISandICF_12-16_PMC; L1_SISandICF_12-16_RUMC; L1_SISbelow12_RUMC; L1_SISandICF_adults_parents_RUMC; L1_SISbelow12_PMC). Documents indicate separate ICFs for adults/parents and for children (12-16 and below 12). Language available: Dutch (translations present).

Investigational Product Name: Diflucan 10 mg/ml, poeder voor orale suspensie
Active Substance: Fluconazole
Modality: Small molecule
Routes Of Administration: Oral
Route: Oral
Authorisation Status: Authorised
Maximum Dose: 800 mg

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