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NCT Number: NCT01420562

Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis

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.

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Key information

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Mucositis Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Isabel Spriet, Pharm.D.

SUB_INVESTIGATOR

Kim Vanstraelen, R.Ph.

PRINCIPAL_INVESTIGATOR

Ludo Willems, Professor

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sampling

Procedure

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.

Primary outcomes

Posaconazole plasma levels and area under the curve in patients with different stages of mucositis

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Isabel Spriet, Pharm.D.

CONTACT

[email protected]

Kim Vanstraelen, R.Ph.

CONTACT

[email protected]

(+32) (0)16342339

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2025
Study completion: 2025
First posted: Aug 19, 2011
Registry last updated: Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting