Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients receiving allogeneic stem cell transplantation - Treated with prophylactic posaconazole: oral suspension (200mg three times daily) or tablet (300mg once daily) to prevent invasive fungal infections
Disqualifiers
Gastroparesis
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
Trial population
Patients on the hematology ward who will receive an allogeneic stem cell transplantation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
blood sampling
Procedure/SurgeryDuring posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: Posaconazole oral suspension1 intervention
Group B: Posaconazole oral tablet1 intervention
Trial outcomes
Primary outcomes
1
Posaconazole plasma levels and area under the curve in patients with different stages of mucositis
Plasma levels of posaconazole will be determined to calculate the area under the curve. These values will be correlated with the stage of mucositis, which will be assessed using citrulline monitoring in plasma. The stage of mucositis will also be assessed using the Daily Oral Mucositis Score (DMS) and Daily Gut Mucositis Score (DGS).
Time frame
Day 0 (day of transplantation), day +7, day +14Sponsors and contacts
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Source ClinicalTrials.gov