Progress update on the WHO–US FDA collaborative project on the review and use of online repository for difficult-to-treat infections

Since 2019, the World Health Organization (WHO) has been collaborating with the United States Food and Drug Administration (US FDA) to assess the merits and use of CURE-ID,^[1] a web-based application that could help clinicians share their experiences in managing difficult-to-treat infectious diseases.

The CURE ID application, developed by US FDA and the National Center for Advancing Translational Sciences (NCATS), a part of the United States National Institutes of Health, allows clinicians to report on novel uses of existing drugs for infectious diseases that lack adequate treatment options, including neglected tropical diseases, emerging infectious threats and infections caused by antimicrobial-resistant organisms. CURE ID captures their experiences in repurposing medicines approved for other conditions, for new indications or for treatment of new populations when faced with failure or lack of approved treatments.

As part of the collaboration, WHO has conducted series of landscape analyses across relevant programmes to identify infectious diseases with treatment gaps, where drug repurposing might offer promising solutions. Consequently, WHO has identified groups of infectious diseases that could benefit from observational data collection through CURE ID to support research hypotheses. Three main disease groups were selected: implantation mycoses (eumycetoma, actinomycetoma, chromoblastomycosis, sporotrichosis), drug-resistant sexually transmitted infections, and selected WHO fungal priority pathogens/diseases^.[2]

For the identified diseases, WHO has mobilized its network of disease experts, WHO collaborating centres and public–private partnerships involved in drug development, and supported the establishment of dedicated CURE ID technical working groups.  As part of the WHO landscape analysis, WHO conducted a global online survey on implantation mycoses in 2022 to solicit information on worldwide diagnostic capacities and drug repurposing for this group of newly recognized neglected tropical diseases^.[3],[4] An implantation mycosis-specific case report form was implemented in CURE ID in October 2023, allowing clinicians globally to enter case reports via the CURE ID website and/or mobile app. Since then, approximately 150 case reports from three countries have been uploaded by research groups through the platform utilizing the reporting form.

A similar approach engaging global experts through surveys is currently under way for the selection of two WHO fungal priority pathogens/diseases to pilot in CURE ID. Other groups of communicable diseases are under investigation for potential piloting in CURE ID.

Additionally, a tailored case report form for Neisseria gonorrhoea treatment failures is under development, with a pilot project planned in three countries with national agencies with established surveillance capacity for drug-resistant cases.

The collection of real-world experience through CURE-ID will provide a resource for others and create an opportunity to identify medicines that warrant further study. This data could potentially support regulatory approval or inform development of WHO guidelines and national policies.

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1. To download and use the CURE ID application, visit https://cure.ncats.io or download “CURE ID” from the App or Play Store. 

2.  WHO fungal priority pathogens list to guide research, development and public health action. Geneva: World Health Organization; 2022 https://iris.who.int/handle/10665/363682).

3. Results of the 2022 global WHO online survey on diagnostic capacities and treatment practices for implantation (‎deep)‎ mycoses. Geneva: World Health Organization; 2023 (https://iris.who.int/handle/10665/367342).

4. Milani B, Dagne DA, Choi HL, Schito M, Stone HA. Diagnostic capacities and treatment practices on implantation mycoses: results from the 2022 WHO global online survey. PLoS Negl Trop Dis. 2023; 17(6):e0011443 (https://doi.org/10.1371/journal.pntd.0011443).