Breaking the mould: challenging the status quo of clinical trial response definitions for invasive fungal diseases-a debate

. 2024 Aug 1;79(8):1786-1793.

doi: 10.1093/jac/dkae158.

Affiliations

¹ University Hospitals Leuven, Department of Haematology and ECMM Excellence Center of Medical Mycology, Campus Gasthuisberg Leuven, Belgium.
² Peter MacCallum Cancer Centre and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
³ Division of Infectious Diseases, ECMM Excellence Center of Medical Mycology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
⁴ Division of Infectious Diseases, and Departments of Internal Medicine and Medical Microbiology and Immunology, University of California-Davis, Sacramento, CA, USA.
⁵ Mycology Reference Centre Manchester, ECMM Excellence Center of Medical Mycology, Manchester University NHS Foundation Trust, Manchester, UK.
⁶ Christian-Doppler Laboratory for Invasive Fungal Infections, Institute of Hygiene and Medical Microbiology, ECMM Excellence Center of Medical Mycology, Medical University of Innsbruck, Innsbruck, Austria.

Johan Maertens et al. J Antimicrob Chemother. 2024.

. 2024 Aug 1;79(8):1786-1793.

doi: 10.1093/jac/dkae158.

¹ University Hospitals Leuven, Department of Haematology and ECMM Excellence Center of Medical Mycology, Campus Gasthuisberg Leuven, Belgium.
² Peter MacCallum Cancer Centre and Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
³ Division of Infectious Diseases, ECMM Excellence Center of Medical Mycology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
⁴ Division of Infectious Diseases, and Departments of Internal Medicine and Medical Microbiology and Immunology, University of California-Davis, Sacramento, CA, USA.
⁵ Mycology Reference Centre Manchester, ECMM Excellence Center of Medical Mycology, Manchester University NHS Foundation Trust, Manchester, UK.
⁶ Christian-Doppler Laboratory for Invasive Fungal Infections, Institute of Hygiene and Medical Microbiology, ECMM Excellence Center of Medical Mycology, Medical University of Innsbruck, Innsbruck, Austria.

No abstract available

References

1. Hoenigl M, Sprute R, Egger Met al. . The antifungal pipeline: fosmanogepix, ibrexafungerp, olorofim, opelconazole, and rezafungin. Drugs 2021; 81: 1703–29. 10.1007/s40265-021-01611-0 - DOI - PMC - PubMed
1. Maertens JA, Verweij PE, Lanuza EFet al. . Olorofim for the treatment of invasive mould infections in patients with limited or no treatment options: comparison of interim results from a phase 2B open-label study with outcomes in historical control populations (NCT03583164, FORMULA-OLS, study 32). Open Forum Infect Dis 2022; 9: Abstract 870. 10.1093/ofid/ofac492.063 - DOI
1. Vazquez JA, Pappas PG, Boffard Ket al. . Clinical efficacy and safety of a novel antifungal, fosmanogepix, in patients with candidemia caused by Candida auris: results from a phase 2 trial. Antimicrob Agents Chemother 2023; 67: e0141922. 10.1128/aac.01419-22 - DOI - PMC - PubMed
1. Banshoya K, Kaneo Y, Tanaka Tet al. . Development of an amphotericin B micellar formulation using cholesterol-conjugated styrene-maleic acid copolymer for enhancement of blood circulation and antifungal selectivity. Int J Pharm 2020; 589: 119813. 10.1016/j.ijpharm.2020.119813 - DOI - PubMed
1. Thompson GR, Soriano A, Skoutelis Aet al. . Rezafungin versus caspofungin in a phase 2, randomized, double-blind study for the treatment of candidemia and invasive candidiasis: the STRIVE trial. Clin Infect Dis 2021; 73: e3647–55. 10.1093/cid/ciaa1380 - DOI - PMC - PubMed