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Sponsored by: |
Radboud University |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00799071 |
The purpose of this study is to find a dose for a twice daily regimen for posaconazole (PSZ) as prophylactic treatment in children with CGD, based on the PSZ trough level.
Condition | Intervention | Phase |
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Chronic Granulomatous Disease |
Drug: posaconazole (PSZ) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Investigation of POsaconazole Prophylaxis in Children With Chronic Granulomatous Disease (CGD): Pharmacokinetics and Tolerability (iPOD) |
Estimated Enrollment: | 20 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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posaconazole: Experimental
posaconazole as antifungal prophylaxis
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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.
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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.
Ages Eligible for Study: | 2 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David M Burger, PharmD PhD | ++31243616405 | d.burger@akf.umcn.nl |
Netherlands | |
AMC | Recruiting |
Amsterdam, Netherlands | |
Contact: M van den Berg | |
Principal Investigator: M van den Berg | |
Netherlands, Gelderland | |
Radboud University Medical Centre Nijmegen | Recruiting |
Nijmegen, Gelderland, Netherlands | |
Contact: David Burger, PharmD PhD ++31243616405 d.burger@akf.umcn.nl | |
Sub-Investigator: Adilia Warris, MD PhD |
Principal Investigator: | David M Burger, PharmD PhD | Radboud University Medical Centre Nijmegen |
Responsible Party: | Radboud University Medical Centre Nijmegen ( Dr. D.M. Burger, hospital pharmacist ) |
Study ID Numbers: | UMCN-AKF 08.01 |
Study First Received: | November 26, 2008 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00799071 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
prophylaxis CGD pharmacokinetics |
Anti-Infective Agents Hematologic Diseases Leukocyte Disorders Granuloma Immunologic Deficiency Syndromes Lymphatic Diseases Anti-Bacterial Agents |
Genetic Diseases, Inborn Granulomatous Disease, Chronic Antifungal Agents Genetic Diseases, X-Linked Chronic Granulomatous Disease Lymphoproliferative Disorders Posaconazole |
Phagocyte Bactericidal Dysfunction Trypanocidal Agents Anti-Infective Agents Antiprotozoal Agents Immune System Diseases Hematologic Diseases Leukocyte Disorders Granuloma Pharmacologic Actions Immunologic Deficiency Syndromes Lymphatic Diseases |
Antiparasitic Agents Pathologic Processes Genetic Diseases, Inborn Therapeutic Uses Antifungal Agents Granulomatous Disease, Chronic Antibiotics, Antifungal Genetic Diseases, X-Linked Lymphoproliferative Disorders Posaconazole |