Biomarker Driven Antifungal Stewardship: The BioDriveAFS Trial. V1.0
Research type
Research Study
Full title
Biomarker Driven Antifungal Stewardship (BioDriveAFS) in Acute Leukaemia – a Multi-Centre Randomised Controlled Trial to Assess Clinical and Cost Effectiveness
IRAS ID
306996
Contact name
Gavin Barlow
Contact email
Sponsor organisation
Hull University Teaching Hospitals NHS Trust
ISRCTN Number
ISRCTN11633399
Duration of Study in the UK
3 years, 3 months, 17 days
Research summary
Acute myeloid leukaemia (AML), high risk myelodysplasia (HRMDS) and Acute Lymphoblastic Leukaemia (ALL) are blood cancers treated by intensive chemotherapy. Prolonged fever is common during chemotherapy and can be due to fungal infection. This may be life-threatening and is difficult to diagnose. Antifungals drugs are often given as a preventive. Antifungals have side effects and overuse may lead to infections that are resistant to them. Alternatively, blood tests can be used to detect fungal infection before symptoms start.
The aim of this study is to determine if less antifungals are used in those having regular blood tests compared to preventative antifungal drugs, without decreasing quality of life.
The study is funded by The NIHR HTA Programme. 500 patients will be recruited from 40 hospitals, they will be allocated to one of these antifungal management groups by chance.
1. Blood tests for fungal infection twice a week. If these are positive or if the patient becomes ill in a way suggesting fungal infection, further tests will be recommended. Antifungals will be recommended if tests suggest a fungal infection is likely.
2. Preventive antifungal drugs. If the patient becomes ill, tests and therapeutic antifungal drugs given based on the opinion of the doctor in charge.
Antifungal management will continue for the duration of the patient’s intensive chemotherapy. Patients will be followed up with questionnaires at 3, 6 and 12 months after starting in the study. The side-effects, the number of fungal infections and deaths as well as value for money for the NHS will be monitored. A process evaluation will be undertaken to evaluate how the intervention is delivered and the experience of healthcare staff and patients.
Based on the results of this study, we will encourage hospitals to review their antifungal use.REC name
South West - Frenchay Research Ethics Committee
REC reference
22/SW/0053
Date of REC Opinion
27 May 2022
REC opinion
Further Information Favourable Opinion