Mycetoma is a slow-growing infection that causes severe disabilities. Infection probably comes from the soil or animal dung and begins most often in the foot, after a cut allows the bacteria or fungus to enter. Current treatments show moderate effectiveness, but due to the length of administration they are less suitable and adapted for patients. They are also unaffordable and cause considerable side effects. Mycetoma is among the most neglected tropical diseases and typically associated with poverty and people who live in remote areas. In 2016, mycetoma was added to the WHO list of Neglected Tropical Diseases.
A randomized clinical trial in Sudan for eumycetoma comparing fosravuconazole, an oral azole originally developed for onychomycosis by Eisai Co., Ltd., to itraconazole, the current standard of care, showed both drugs to be effective, with fosravuconazole having practical advantages over the current standard of care – including once weekly as opposed to twice-daily administration.
With the process of registering fosravuconazole ongoing in Sudan, DNDi teams and partners are now working to promote access to the new treatment for patients with eumycetoma in the country through an early access protocol to be implemented by the Mycetoma Research Center. In parallel, the project is working to expand registration and access to both fosravuconazole and WHO-prequalified generic itraconazole in other endemic countries. The project also aims to support epidemiological studies to understand the burden and distribution of mycetoma in endemic areas while advocating for research to address the unmet treatment needs of children and women of childbearing potential and the development of new translational models to guide further research and development efforts for eumycetoma.
Project updates
2024
A field visit to Ethiopia (Bahir Dar, Dessie, Boru Meda, Arba Minch) was conducted in April to assess current medical practices and local treatment needs, establish partner networks, and collect existing epidemiological data. Retrospective data collection of mycetoma cases in medical and laboratory records for a 10-year period (2014-2023) began in July for Senegal and September for India, with the aim of providing information on existing, documented mycetoma cases. In December, a burden of disease study was started involving house-to-house visits from health extension workers in four regions of Ethiopia (Afar, Amhara, Southern Nations and Tigray) to screen patients for mycetoma and refer suspected cases to the nearest health facility for diagnosis and management.
2023
Three expert meetings organized by DNDi in Nairobi, Geneva, and Utrecht brought together representatives from Africa, South America, South Asia, and Europe to set out a framework for much-needed epidemiological studies to address knowledge gaps on the burden and distribution of mycetoma. The meetings also examined important aspects of clinical trial design and drug development, including the need to develop medicines that are not only simpler and more effective, but also suitable for children and women of childbearing potential. In July, a field visit was conducted in Senegal to assess current practices and local treatment needs, establish partner networks, and collect epidemiological data.