Mycetoma is a chronic subcutaneous neglected tropical disease (NTD), recognized by WHO as a skin NTD in 2016. It is characterized by the formation of tumorous lesions and the presence of multiple sinuses from which grains are secreted. Mycetoma is caused by bacteria (actinomycetoma) or fungi (eumycetoma), 1 which are found embedded in the grains. 2 The colour and substance of the grain are dependent on the etiologic agent. 1 Within the fungal hyphae inside the grain, cell wall components such as chitin and beta-glucan are found. 2 In bacterial grains, L-and meso-isomers of diaminopimelic acid can be found. 3 To ensure proper patient management, discrimination of the two types is needed. 4 Currently, the gold standard diagnosis relies on histology and culture. 5 However, this has low diagnostic accuracy, is time-consuming and invasive as a deep surgical biopsy is needed. Molecular assays have been developed to solve some of these issues, 5 however,
Eumycetoma, the fungal form of the neglected tropical disease mycetoma, is a crippling infectious disease with low response rates to currently available antifungal drugs. In this study, a series of natural naphthoquinones and anthraquinones was evaluated for their activity against Madurella mycetomatis, which is the most common causative agent of eumycetoma. The metabolic activity of Madurella mycetomatis as well as the viability of Galleria mellonella larvae upon treatment with quinones was investigated. Several hydroxy‐substituted naphthoquinones exhibited activity against Madurella mycetomatis. In particular, naphthazarin (5,8‐dihydroxy‐1,4‐naphthoquinone) was identified as a considerably active antifungal compound against Madurella mycetomatis (IC50=1.4 μM), while it showed reduced toxicity to Galleria mellonella larvae, which is a well‐established in vivo invertebrate model for mycetoma drug studies.
Objective
Mycetoma is a neglected tropical disease caused by more than 70 different microorganisms and identified by the WHO as one of the high‐priority diseases for developing diagnostic tests. To ensure the production of diagnostic assays for use by clinical staff in endemic regions, target product profiles (TPPs) were designed.
Methods
We describe the development of two TPPs: one for a diagnostic test able to identify the causative agent of mycetoma and another that would determine when treatment could be stopped. The TPPs were developed by considering product use, design, performance, product configuration and costs.
Results
Version 1.0 TPPs for two uses were posted by WHO for a 1‐month online public consultation on 25 October 2021, and the final TPP was posted online on 5 May 2022.
Conclusion
A major difficulty encountered in developing both TPPs was the large number of agents able to cause mycetoma and the lack of specific biomarkers for most of them.
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