Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD) (iPOD)
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|ClinicalTrials.gov Identifier: NCT00799071|
Recruitment Status : Completed
First Posted : November 27, 2008
Last Update Posted : May 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Granulomatous Disease||Drug: posaconazole (PSZ)||Phase 2|
At this moment itraconazole is the drug of first choice in the prophylaxis of fungal infections in children with CGD. Breakthrough fungal infections while on itra-conazole prophylaxis are described in literature indicating the need for a drug with a broader antifungal spectrum. PSZ might provide in this need. PSZ may also have a clinical safety and tolerability advantage over other antifungal agents. Because PSZ is metabolized through phase II glucuronidation it is less common to be subject to drug interactions. PSZ is known to be a CYP3A4 inhibitor, but does not inhibit other CYP enzymes, therefore it may exhibit fewer drug interactions as compared with other azole antifungal agents.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of POsaconazole Prophylaxis in Children With Chronic Granulomatous Disease (CGD): Pharmacokinetics and Tolerability (iPOD)|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||August 2010|
posaconazole as antifungal prophylaxis
Drug: 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 Name: Noxafil
- Posaconazole trough levels [ Time Frame: Day 10; 20; 30 ]
- adverse events monitoring [ Time Frame: entire study ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799071
|Radboud University Medical Centre Nijmegen|
|Nijmegen, Gelderland, Netherlands|
|Principal Investigator:||David M Burger, PharmD PhD||Radboud University Medical Centre Nijmegen|