Actively Recruiting
Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-15
55
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the pharmacokinetics of posaconazole in patients undergoing allogeneic hematopoietic stem cell transplantation who experience different stages of mucositis caused by chemotherapy and total body irradiation. The study aims to calculate pharmacokinetic parameters and evaluate the trough levels of posaconazole to understand how the medication behaves during mucositis. Participants will receive posaconazole either as an oral suspension or, once available, as oral tablets, both used as prophylactic agents to prevent invasive fungal infections. Blood samples will be collected on the day of transplantation (day 0), day 7, and day 14, including nine samples at each timepoint to calculate the area under the concentration-time curve (AUC). Additionally, citrulline levels will be measured to objectively assess the severity of mucositis. During the study, participants will undergo scheduled blood sampling to measure posaconazole plasma levels and evaluate mucositis severity. The main outcome measured is the posaconazole plasma levels and AUC at days 0, 7, and 14. The study will last at least two weeks post-transplantation, focusing on drug exposure and mucositis impact, with careful monitoring throughout this period.
CONDITIONS
Brief Title
Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Age between 18 and 75 years
You will not qualify if you...
- Gastroparesis
- Vomiting or diarrhea within 2 hours after intake of posaconazole
- Concomitant use of potent inducers of enzyme UGT1A4 (e.g., carbamazepine, phenytoin, phenobarbital, rifabutin, rifampicin)
- Age under 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 days
Participants receiving posaconazole prophylaxis are observed with blood sampling to measure drug levels and evaluate mucositis severity.
3 visits on day 0 (transplantation), day 7, and day 14
Trial Site Locations
Total: 1 location
1
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
K
Kim Vanstraelen, R.Ph.
I
Isabel Spriet, Pharm.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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