Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Unknown status

CT.gov ID

NCT01420562

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)	Procedure: blood sampling

Study Design

Study Type:

Observational

Anticipated Enrollment :

55 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: blood 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.
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.	Procedure: blood 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.

Arm

Intervention/Treatment

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.

Procedure: blood 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.

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.

Procedure: blood 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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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