Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD)
NCT ID: NCT00799071
Last Updated: 2020-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2009-02-28
2010-08-31
Brief Summary
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Detailed Description
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Treatment of children is still off-label use. No data have been published to date on the exposure of PSZ in children under the age of 8 or in children with CGD. There is an urgent need to study the use of PSZ in these young children. Furthermore, the current regimen for antifungal prophylaxis requires a three times daily administration of PSZ. For this specific purpose less complex dosing schedules are warranted thus defining the need to examine a twice daily schedule.
As the tolerability and pharmacokinetics are unknown in patients under the age of 8 years and only limited data are available for age groups 8 to 16 years, we propose a feasibility study of a twice daily regimen of PSZ prophylaxis in CGD patients. With this information available we can suggest a dosage for future prophylaxis in this patient group.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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posaconazole
posaconazole as antifungal prophylaxis
posaconazole (PSZ)
Intake of PSZ oral suspension 40mg/ml twice daily with food. Starting dose is based on bodyweight. The dosage will be adjusted if the exposure is not adequate based on PSZ trough level on Day 10 and 20.
Interventions
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posaconazole (PSZ)
Intake of PSZ oral suspension 40mg/ml twice daily with food. Starting dose is based on bodyweight. The dosage will be adjusted if the exposure is not adequate based on PSZ trough level on Day 10 and 20.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is at least 2 years of age and younger than 17 years of age on the day of the first dosing.
* Parents or legal representative, and children where appropriate, willing and able to give informed consent.
Exclusion Criteria
* Therapy with any medicinal product for which an effect on PSZ is expected. If patient is undergoing therapy with any medicinal product which may be effected by PSZ, the patient is included on condition that the investigator judges that the effects are not clinically relevant. This should be clearly recorded.
* Documented history of sensitivity/idiosyncrasy to PSZ.
* Results of serum biochemistry and hematology testing are not higher than 3x the upper limit of normal. If the results exceed these limits, the patient is included on condition that the investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* Relevant history or presence of cardiovascular disorder or renal and hepatic disorder.
* History of or current abuse of drugs, alcohol or recreational substances.
* Participation in a trial with an investigational drug within 60 days prior to the first dose.
2 Years
16 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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David M Burger, PharmD PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Centre Nijmegen
Locations
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Radboud University Medical Centre Nijmegen
Nijmegen, Gelderland, Netherlands
AMC
Amsterdam, , Netherlands
Countries
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References
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Welzen ME, Bruggemann RJ, Van Den Berg JM, Voogt HW, Gilissen JH, Pajkrt D, Klein N, Burger DM, Warris A. A twice daily posaconazole dosing algorithm for children with chronic granulomatous disease. Pediatr Infect Dis J. 2011 Sep;30(9):794-7. doi: 10.1097/INF.0b013e3182195808.
Related Links
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Pediatr Infect Dis J. 2011 Sep;30(9):794-7. A twice daily posaconazole dosing algorithm for children with chronic granulomatous disease.
Other Identifiers
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UMCN-AKF 08.01
Identifier Type: -
Identifier Source: org_study_id