Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis
1 other identifier
observational
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2011
CompletedFirst Posted
Study publicly available on registry
August 19, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJuly 15, 2024
July 1, 2024
13.5 years
August 16, 2011
July 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
Interventions
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.
Eligibility Criteria
Patients on the hematology ward who will receive an allogeneic stem cell transplantation.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kim Vanstraelen, R.Ph.
Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2011
First Posted
August 19, 2011
Study Start
September 1, 2011
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
July 15, 2024
Record last verified: 2024-07