Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
NCT ID: NCT01420562
Last Updated: 2024-07-15
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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RECRUITING
55 participants
OBSERVATIONAL
2011-09-30
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Posaconazole oral suspension
One group of patients will receive posaconazole oral suspension as prophylactic agent.
Blood sampling: At day of transplantation, day 7 and 14, 9 blood samples will be collected to calculate AUC. Moreover, citrulline will be determined to objectively evaluate the severity of mucositis.
blood sampling
During posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.
Posaconazole oral tablet
Once the oral tablet is available for adminstration to patients, a second group of patients will receive these tablets as prophylactic agent.
Blood sampling: At day of transplantation, day 7 and 14, 9 blood samples will be collected to calculate AUC. Moreover, citrulline will be determined to objectively evaluate the severity of mucositis.
blood sampling
During posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.
Interventions
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blood sampling
During posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Vomiting or diarrhea within 2 hours after intake of posaconazole
* Concomitant administration of potent inducers of the enzyme UGT1A4: carbamazepine,phenytoin, phenobarbital, rifabutin, rifampicin,...
* Age under 18 years
18 Years
75 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Kim Vanstraelen, R.Ph.
Role: PRINCIPAL_INVESTIGATOR
Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
Locations
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University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Central Contacts
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Other Identifiers
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ML7267
Identifier Type: -
Identifier Source: org_study_id
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