Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis

Conditions
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Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Intervention / Treatment
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* Procedure: blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Posaconazole oral suspension<br>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. | Procedure: blood sampling<br>* 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.<br>|
| Posaconazole oral tablet<br>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. | Procedure: blood sampling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Day 0 (day of transplantation), day +7, day +14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allogeneic HSCT, posaconazole, prophylaxis, mucositis, pharmacokinetics