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Pharmacokinetics of Fluconazole in Children (2-18 Years)

NCT05130723 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-10-26

No results posted yet for this study

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.

Conditions

  • Invasive Fungal Infections

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Roger JM Brüggemann, PharmD, PhD · Radboud University Medical Center

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-18
Primary Completion
2023-10-01
Completion
2023-10-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05130723 on ClinicalTrials.gov