Host directed medicine in invasive fungal infection

Informazioni relative al progetto

HDM-FUN

ID dell’accordo di sovvenzione: 847507

DOI

10.3030/847507

Data della firma CE 6 Dicembre 2019

Data di avvio 1 Gennaio 2020

Data di completamento 30 Giugno 2026

Finanziato da

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Costo totale

€ 10 158 439,05

Contributo UE

€ 9 998 170,00

Coordinato da

STICHTING RADBOUD UNIVERSITAIR MEDISCH CENTRUM
Netherlands

Periodic Reporting for period 4 - HDM-FUN (Host directed medicine in invasive fungal infection)

Periodo di rendicontazione: 2024-07-01 al 2025-12-31

Sintesi del contesto e degli obiettivi generali del progetto

Despite novel treatment options and diagnostic tools, invasive fungal infections are still associated with an unacceptably high mortality and morbidity. Experts believe that a host-directed approach is needed to overcome this clinical challenge. No study to date in invasive fungal infection has integrated a host-directed strategy into a clinical trial. This consortium proposes for the first time a trans-disciplinary approach to identify personalized therapeutic and prophylactic strategies based on host-pathogen factors. We believe that we need such a personalized medicine approach in order to advance the aim of improved outcome in invasive fungal infection, and that, together with the exponential knowledge that has been gained in host-fungal interaction over the last two decades, it is time to move towards proof-of-principle clinical trials that can save lives of patients.
To this aim two clinical trials of host-directed medicine approaches will be performed: an immunotherapy trial with interferon gamma (IFNγ in patients with candidemia and a prospective observational trial in patients with influenza to identify patients at risk for aspergillosis that might benefit from antifungal prophylaxis.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

Both trials remain open for recruitment. This reporting period focused on accelerating enrolment (with WP2-Greece completed), maintaining robust safety oversight through three DSMB interim reviews at 20, 40, and 60 patients with no safety concerns, and scaling centralized biobanking with active sample distribution for downstream analyses. Recruitment has progressed substantially, with 64 patients included to date and continued enrolment in participating countries; Greece contributed a notable number of Candida auris cases, highlighting the translational relevance of the HDM-FUN platform. The eCRF is fully operational across 13 sites, prospective sampling continues, and the IAPA trial extension supports completion of the final recruitment season. Genetic, immunological, immunometabolic, and microbiome analyses advanced across WPs 5–7, including biomarker development (PTX3, suPAR, galectin-3) and integration of novel C. auris data. WP8 activities progressed with social science work, strengthened international engagement, and establishment of the International Immunotherapy Society for Fungal Diseases (IISFD), with its inaugural meeting planned for June 2026 in Crete.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

HDM-FUN is a unique project with the ambition to change treatment of fungal infection and influence daily clinical practice. It has the ambitious goal of introducing a new paradigm in host-directed medicine, namely the personalization of treatment and prevention of fungal infections by stratification based on host and pathogen factors. At this moment, all clinical trials on immunotherapy in infectious diseases have had a ‘one size fits all’ approach. Because the immune status of ICU patients is substantially different, such an approach is eventually deemed to fail. HDM-FUN has setup its design of clinical trials and research in such a way that we will be able to overcome this hurdle after completion of the current proposal.
HDM-FUN will contribute to (i) creating societal impact by changing clinical practice to better control infectious diseases and reduce their burden, thereby ensuring health and well-being for all, at every stage of life; (ii) reducing antimicrobial resistance; and (iii) developing HPF-based targeted treatments and preventive measures, HPF-biomarker based diagnostics and novel standards with respect to clinical trials and protocols.

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HDM-FUN small teams

HDM-FUN Management scheme