1st December 2021

York Trials Unit (University of York), in collaboration with Hull University Teaching Hospitals NHS Trust and Hull York Medical School, are calling for expressions of interest from hospitals around the UK to take place in the BioDriveAFS trial. This research is funded by the National Institute for Health Research.

Background

Antifungal Stewardship is about the responsible use of antifungal drugs in a way that focuses on treating patients with the right drug at the right time whilst preserving future effectiveness and minimising harm to the patient and healthcare costs. It is vital to find the best way to optimise antifungal use without increasing fungal infections or patient harm.

Acute Myeloid leukaemia (AML), Myelodysplasia and Acute Lymphoblastic Leukaemia (ALL) are blood cancers often treated by intensive chemotherapy. Patients who receive intensive chemotherapy are at higher risk of invasive fungal infections. These infections are difficult to diagnose and treat and can be potentially life-threatening. Different ways have been used to prevent fungal infections in patients with acute leukaemia. Antifungal drugs are often given as prophylaxis. This is the usual way to prevent fungal infections in AML/HRMDS/ALL patients in the UK. Clinicians often treat patients as if they have a fungal infection when they become ill, even if prophylaxis has been used. This approach means that all patients take an antifungal drug to prevent a relatively small total number of invasive fungal infections, but many patients still receive additional systemic antifungal therapy.

Antifungals have side effects and overuse is likely to fuel antifungal resistance, a growing concern. Another way, used in some hospitals, is not to give patients prophylaxis, but to monitor them closely with biomarker blood tests and then investigate and treat fungal infections early if suspected based on the results.

The BioDriveAFS Trial

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. 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 an 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 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.

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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