6th December 2022

Are you interested in being involved in a potentially paradigm-changing trial? York Trials Unit (University of York), in collaboration with Hull University Teaching Hospitals NHS Trust and Hull York Medical School, are once again calling for expressions of interest from hospitals to take part in the BioDriveAFS trial, designed to change the approach to invasive fungal infection management in acute leukaemia patients undergoing intensive chemotherapy.

Designed to respond to both national and global priorities, this open-label randomised controlled trial will investigate the safety, clinical efficacy and cost-effectiveness of a biomarker/diagnostic-driven approach to invasive fungal infection management in acute leukaemia patients undergoing intensive chemotherapy – something which is a key priority to patients.

We will compare a biomarker monitoring approach, using galactomannan and beta-D-glucan, without antifungal prophylaxis, versus the prevailing standard of care in most centres in the UK which is antifungal prophylaxis plus reactive testing when indicated in patients undergoing intensive chemotherapy for acute leukaemia (AML or ALL) or a high-risk myelodysplastic syndrome (HRMDS). Our safety and efficacy core outcomes will be therapeutic and overall antifungal drug use, health-related quality of life, and the incidence of invasive fungal infection. A mixed methods process evaluation component will be integrated within the trial, which will explore the barriers and facilitators to the implementation of this treatment strategy through qualitative (interviews with hospital staff and patients) and quantitative data collection.

Participants will be adult patients (16 years or older) identified in participating NHS hospitals who have a new diagnosis or relapse of AML, ALL or HRMDS and who will be treated with intensive chemotherapy. As for Principle Investigators (PIs), we are flexible, but we do require a haematologist to be a co-PI, or at least actively involved, as they are needed for patient identification and recruitment.

In return for their participation, sites will get an excess treatment cost per patient to account for the extra biomarkers in the context of reducing their antifungal prophylaxis use in intervention patients, plus a per-patient recruitment cost (the total per-patient payment, assuming all follow-up is complete up to 1 year is £680.16.) All co-PIs and PIs will also be listed as authors in the primary paper. Moreover, participants will be taking part in a hugely important study, which aims to positively impact patient outcomes, as well as reduce the spread of AMR.

To register your interest (and for any queries), the proposed principal investigator or their representative should please complete this form, which should be returned to Lydia Flett via email: biodrive-group@york.ac.uk


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