Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Treatments: Procedure: blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT01420562

ML7267

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

55 participants in 2 patient groups

Posaconazole oral suspension

Description:

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.

Treatment:

Procedure: blood sampling

Posaconazole oral tablet

Description:

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.

Treatment:

Procedure: blood sampling