Pharmacokinetics of Fluconazole in Children (2-18 Years)
FOCUS
2 other identifiers
observational
30
1 country
2
Brief Summary
30 pediatric patients aged 2-18 years receiving fluconazole as part of standard care for the treatment or prophylaxis of an invasive fungal infection will be included in the study. Between day 2 and 10, 6 samples will be collected on two days. In the case a patient switches from oral to intravenous therapy, an additional PK-day consisting of 3 samples will be scheduled. Fluconazole plasma concentrations will be determined. A pharmacokinetic model will be fitted to the data from all individuals simultaneously. Data will be analysed using non-linear mixed effects modelling (NONMEM). Monte Carlo simulations will guide the establishment of an improved fluconazole dosing regimen for pediatric and adolescent patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2022
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedStudy Start
First participant enrolled
October 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedOctober 26, 2022
October 1, 2022
12 months
November 10, 2021
October 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target attainment of fluconazole in pediatric patients
Percentage of pediatric patients reaching the predetermined pharmacokinetic/pharmacodynamic (PK/PD) target (an area-under-the-concentration-time-curve (AUC) above 400 mg\*h/L)
At steady state: at day 2 after start of fluconazole therapy
Study Arms (1)
Patients
Pediatric patients aged 2-18 years administered with fluconazole for the treatment or prophylaxis of invasive fungal infections.
Eligibility Criteria
Pediatric patients aged 2-18 years treated with fluconazole for the prophylaxis or management of an invasive fungal infection are eligble for inclusion. In total, 30 patients will be included. Patients are treated as per local protocol. Only patients managed with a CVC or arterial line from which blood can be obtained are included to ensure the non-interventional nature of the study.
You may qualify if:
- Subject is treated with fluconazole for prophylaxis or treatment of an invasive fungal infection;
- Subject is 2 - 18 years of age on the day of the first fluconazole dosing
- Subject is managed with a central venous catheter or arterial line from which blood can be obtained.
You may not qualify if:
- Subject is managed by means of an extracorporeal clearance technique;
- Subject has previously participated in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Radboud University Medical Center
Nijmegen, Netherlands
Prinses Máxima Centrum voor Kinderoncologie
Utrecht, Netherlands
Biospecimen
Whole blood samples will be obtained an processed to obtain plasma. Fluconazole plasma levels will be measured.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roger JM Brüggemann, PharmD, PhD
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 23, 2021
Study Start
October 18, 2022
Primary Completion
October 1, 2023
Study Completion
October 1, 2023
Last Updated
October 26, 2022
Record last verified: 2022-10