Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Conditions
Keywords
allogeneic HSCT, posaconazole, prophylaxis, mucositis, pharmacokinetics
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.
Interventions
PROCEDUREblood 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.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Belgium
Contacts
Primary ContactKim Vanstraelen, R.Ph.
Backup ContactIsabel Spriet, Pharm.D.
Outcome results
None listed