Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Clinical Trial

Official title:

Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01420562
• Other study ID #: ML7267
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2011
• Last updated: January 13, 2015
• Start date: September 2011

Study information

• Verified date: February 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Kim Vanstraelen, R.Ph.
• Phone: (+32) (0)16342339
• Email: kim.vanstraelen[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
• Mucositis

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No