Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
Recruiting
- Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- Interventions
- Procedure: blood sampling
- Registration Number
- NCT01420562
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 55
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Posaconazole oral suspension blood sampling 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 blood sampling 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.
- Primary Outcome Measures
Name Time Method Posaconazole plasma levels and area under the curve in patients with different stages of mucositis Day 0 (day of transplantation), day +7, day +14 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospitals Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium