Pharmacokinetics of fluconazole given orally or intravenously as prophylaxis or therapy to children and adolescents with invasive fungal infections

Phase 4

Conditions: fungal infection
10017528

Registration Number: NL-OMON51517

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

1. Subject is managed by means of an extracorporeal clearance technique;
2. Subject has previously participated in this study.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters/endpoints:<br /><br>Since the primary objective of this study is to establish an improved<br /><br>fluconazole dosing regimen for paediatric and adolescent patients aged 2-18<br /><br>years, we aim to describe fluconazole pharmacokinetics in this patient<br /><br>population by means of population pharmacokinetic (pop-PK) modelling. The<br /><br>pharmacokinetic parameters of the developed pop-PK model are among others,<br /><br>clearance (CL), volume of distribution (Vd) and exposure described by the area<br /><br>under the concentration-time curve (AUC). With the developed model, simulations<br /><br>will be performed to estimate the percentage of patients reaching the<br /><br>predefined PK target of AUC above 400 mg*h/L. We subsequently aim to establish<br /><br>an improved fluconazole dosing regimen for the studied population which will<br /><br>consist of a loading dose and a maintenance dose that will result in adequate<br /><br>fluconazole exposure in these patients. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other study parameters are factors that might influence the primary study<br /><br>parameters, the covariates. Since this is an observational study, potential<br /><br>covariates will only be explored. Covariates of interest are renal clearance<br /><br>and body weight. Another study parameter that will be explored is the oral<br /><br>bioavailability (F) of fluconazole, which is the percentage of the drug that is<br /><br>systemically available after oral administration compared to the exposure after<br /><br>intravenous administration. </p><br>