Evaluating how posaconazole works in transplant patients with mucositis
Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
This study is testing how the antifungal drug posaconazole works in transplant patients who have mouth sores from treatment to see if it can help prevent infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT01420562 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the pharmacokinetics of posaconazole in patients undergoing allogeneic hematopoietic stem cell transplantation who are experiencing mucositis. By measuring the trough levels of posaconazole, the study seeks to understand how the drug behaves in the body at different stages of mucositis, which can occur due to chemotherapy and total body irradiation. Blood samples will be collected from participants receiving prophylactic posaconazole to prevent invasive fungal infections. The findings may help optimize antifungal prophylaxis in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults receiving allogeneic stem cell transplantation who are being treated with prophylactic posaconazole.
Not a fit: Patients with conditions like gastroparesis or those experiencing vomiting or diarrhea shortly after taking posaconazole may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved antifungal treatment strategies for patients undergoing stem cell transplantation.
How similar studies have performed: While this study focuses on a specific patient population, similar pharmacokinetic studies have shown promise in optimizing antifungal therapies in transplant patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leuven, Vlaams-Brabant
- University Hospitals Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Principal investigator: Kim Vanstraelen, R.Ph. — Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
- Study coordinator: Kim Vanstraelen, R.Ph.
- Email: kim.vanstraelen@uzleuven.be
- Phone: (+32) (0)16342339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.