Invasive Fungal InfectionsFOCUSNCT05130723
Pharmacokinetics of Fluconazole in Children (2-18 Years)
An observational study of Invasive Fungal Infections, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Invasive Fungal Infections
- How many people
- 30 participants
- Where
- 2 sitesNetherlands
- Study dates
- 18 Oct 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Subject is managed by means of an extracorporeal clearance technique;
- Subject has previously participated in this study.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen
Anouk Jansen
Roger Brüggemann
- Not yet recruiting
Prinses Máxima Centrum voor Kinderoncologie
Utrecht
Tom Wolfs
About this study
Official title: Pharmacokinetics of Fluconazole Given Orally or Intravenously as Prophylaxis or Therapy to Children and Adolescents With Invasive Fungal Infections
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.
Read the detailed description
Fluconazole has been available since 1990, however a limited number of studies addressed the pharmacokinetics (PK) of fluconazole in children and adolescent patients. Solid PK data are lacking, despite there being expected variation due to physiological differences with adults likely resulting in significant clinical impact. Especially in the paediatric population where fluconazole is extensively used, including in patients who have moderate to severe renal function disturbances, this information is needed. Therefore, it seems prudent to conduct a study in a cohort of paediatric patients who receive fluconazole as prophylaxis or treatment. The primary objective of the study is to establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years.
A total of pediatric 30 patients will be included in this observational PK-study. Patients will receive standard fluconazole therapy according to (local) protocol. Blood samples will be collected from already placed arterial or central venous catheter.
Between day 2 and 10, six blood samples will be collected for the purpose of PK analysis. Samples will be collected on two different days. On the first PK-day, 3 samples will be collected on t = 0, 1, and 5 hours after fluconazole administration and on the second PK-day, 3 samples will be collected on t = 0.5, 3, and 7 hours after fluconazole administration.
If the patient is expected to switch from iv to oral therapy or vice versa within an additional 30 days, the patient will remain in the study to collect data on absolute oral bioavailability. An additional PK-curve of maximum 3 samples may be drawn.
Plasma concentrations of fluconazole will be measured in all available samples by means of a validated Liquid Chromatography with tandem mass spectrometry (LC-MS-MS) method.
A pharmacokinetic model will be fitted to the data from all individuals simultaneously. Data will be analysed using non-linear mixed effects modelling (NONMEM).After selection of the final model, a simulation study is performed using this model to assess exposure following various dosing regimens.
- Conditions
- Invasive Fungal Infections
- Keywords
- Pharmacokinetics, Antifungal drugs, Pediatrics
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Pediatric patients aged 2-18 years administered with fluconazole for the treatment or prophylaxis of invasive fungal infections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At steady state: at day 2 after start of fluconazole therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start18 Oct 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger JM Brüggemann, PharmD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130723
- Sponsor's protocol ID
- UMCN-AKF-21.05
- Other IDs
- 2021-006868-24
- Acronym
- FOCUS
- Status last verified
- Oct 2022
- First submitted
- 10 Nov 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Fluconazole Given Orally or Intravenously as Prophylaxis or Therapy to Children and Adolescents With Invasive Fungal Infections
- ClinicalTrials.gov ID
- NCT05130723
- Acronym / sponsor ID
- FOCUS / UMCN-AKF-21.05
- Conditions
- Invasive Fungal Infections
- Keywords
- Pharmacokinetics, Antifungal drugs, Pediatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fluconazole has been available since 1990, however a limited number of studies addressed the pharmacokinetics (PK) of fluconazole in children and adolescent patients. Solid PK data are lacking, despite there being expected variation due to physiological differences with adults likely resulting in significant clinical impact. Especially in the paediatric population where fluconazole is extensively used, including in patients who have moderate to severe renal function disturbances, this information is needed. Therefore, it seems prudent to conduct a study in a cohort of paediatric patients who receive fluconazole as prophylaxis or treatment. The primary objective of the study is to establish an improved fluconazole dosing regimen for paediatric and adolescent patients aged 2-18 years.
A total of pediatric 30 patients will be included in this observational PK-study. Patients will receive standard fluconazole therapy according to (local) protocol. Blood samples will be collected from already placed arterial or central venous catheter.
Between day 2 and 10, six blood samples will be collected for the purpose of PK analysis. Samples will be collected on two different days. On the first PK-day, 3 samples will be collected on t = 0, 1, and 5 hours after fluconazole administration and on the second PK-day, 3 samples will be collected on t = 0.5, 3, and 7 hours after fluconazole administration.
If the patient is expected to switch from iv to oral therapy or vice versa within an additional 30 days, the patient will remain in the study to collect data on absolute oral bioavailability. An additional PK-curve of maximum 3 samples may be drawn.
Plasma concentrations of fluconazole will be measured in all available samples by means of a validated Liquid Chromatography with tandem mass spectrometry (LC-MS-MS) method.
A pharmacokinetic model will be fitted to the data from all individuals simultaneously. Data will be analysed using non-linear mixed effects modelling (NONMEM).After selection of the final model, a simulation study is performed using this model to assess exposure following various dosing regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Pediatric patients aged 2-18 years administered with fluconazole for the treatment or prophylaxis of invasive fungal infections. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Subject is managed by means of an extracorporeal clearance technique;
- Subject has previously participated in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target attainment of fluconazole in pediatric patients
Time frame: At steady state: at day 2 after start of fluconazole therapy
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Invasive Fungal Infections
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
Invasive Mold Infections
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger JM Brüggemann, PharmD, PhD principal investigator
Radboud University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infections, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anouk ME Jansen, PharmD (+31650155750, anouk.me.jansen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target attainment of fluconazole in pediatric patients (time frame: At steady state: at day 2 after start of fluconazole therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.