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Chagas disease, also known as American trypanosomiasis, is a potentially life-threatening illness caused by the protozoan parasite Trypanosoma cruzi. About 6–7 million people worldwide are estimated to be infected with T. cruzi. The disease is found mainly in endemic areas of 21 continental Lati
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n American countries, where it has been mostly transmitted to humans and other mammals by contact with faeces or urine of triatomine bugs (vector-borne), known as kissing bugs, among many other popular names, depending on the geographical area.
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Die Infektion wird durch nachtaktive, blutsaugende Raubwanzen übertragen. Während des Blutsaugens scheiden die infizierten Wanzen Trypanosomen aus, die Bindehaut, Schleimhäute, Abschürfungen und Hautverletzungen einschließlich der Bißwunde kontaminieren können. Die Übertragung kann auch durc
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h Bluttransfusion erfolgen, wenn das Blut von einem infizierten Spender stammt. Auch kongenitale Infektionen, verursacht durch Parasiten, die während der Schwangerschaft die Plazenta passieren, sind möglich. Der Erreger, Trypanosoma cruzi, infiziert viele Spezies.
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DOI: 10.5772/intechopen.102891Little progress has been made since the 1960s and 19. 70s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and opera
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tional challenges in the clinical drug development of a novel antitrypanosomal agent for Chagas disease. The various elements that contribute to a robust assessment of treatment effect including dose selection, choice of patient population, trial methodology, endpoint measures, and regulatory perspectives are discussed. The learnings herein should serve as resource to help researchers and other stakeholders optimize their clinical development plans and speed delivery of new medicines to patients with Chagas disease.
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