Clinical trial

Pharmacokinetics Study of Posaconazole in Haematology Patients Receiving Standard of Care Treatment With Oral Posaconazole Prophylaxis for Invasive Fungal Infection

Name

2017.105

Description

The purpose of the study is to investigate the pharmacokinetics of oral dosage of Posaconazole which is routinely administered as a standard care prophylaxis for patients undergoing cancer treatments.

Trial arms

Trial start

2019-08-01

Estimated PCD

2023-12-30

Trial end

2023-12-30

Status

Recruiting

Phase

Early phase I

Treatment

Posaconazole pharmacokinetics

Blood samples will be collected on Days 7, 14 and 21 from the onset of Posaconazole prophylactic treatment If significant diarrhoea occurs, additional blood samples will be collected twice weekly until symptoms resolve. All blood samples will be used for Posaconazole pharmacokinetics study.

Arms:

Posaconazole prophylaxis

Other names:

Blood sampling

Size

100

Primary endpoint

Pre-dose plasma Posaconazole concentrations

On days 7, 14 and 21 of Posaconazole prophylaxis course, when significant diarrhea occurs, when active gastrointestinal graft versus host disease occurs.

Eligibility criteria

Inclusion Criteria: * Adult (≥18 years old) haematology patients receiving Posaconazole prophylaxis in the inpatient setting as standard of care. * Able to give informed consent. Exclusion Criteria: * Unable to give informed consent.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-03-29

1 organization

1 product

7 indications

Organization

Melbourne Health

Product

Posaconazole

Indication

Posaconazole

Indication