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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling | Procedure | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients on the hematology ward who will receive an allogeneic stem cell transplantation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kim Vanstraelen, R.Ph. | Contact | (+32) (0)16342339 | kim.vanstraelen@uzleuven.be | |
| Isabel Spriet, Pharm.D. | Contact | isabel.spriet@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Kim Vanstraelen, R.Ph. | Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D009057 |
| Stomatognathic Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |