CryptoT&T project aims to evaluate the clinical effectiveness of a low-cost point-of-care test, together with access to specific drug treatment, in reducing the duration of diarrhea induced by cryptosporidiosis (infection by the protozoan Cryptosporidium, which is acquired through fecal-oral transmission).
Diarrhea is one of the leading cause of infant mortality in low-income countries. The results of the multicenter study on diarrhea in children under 5, called GEMS (The Global Enterics Multicentric Study) conducted in sub-Saharan African countries, including Mozambique and Southeast Asia between 2008-2010, showed that Cryptosporidium was the third leading cause of diarrhea in this age group. On the other hand, Cryptosporidium was one of the three pathogens associated with an increased risk of death in children aged 12-23 months, highlighting the clinical importance of this pathogen.
The multicenter study, coordinated by the University of Bergen in Norway, has a duration of 4 years (2025-2028) and will be implemented in Ethiopia by the Armauer Hansen Research Institute (AHRI) and in Mozambique by the Manhiça Health Research Center (CISM), where the aim is to estimate the effectiveness of a low-cost point-of-care test, followed by specific treatment for cryptosporidiosis with nitazoxanide (an antiparasitic drug), on the duration of diarrhea in children presenting at health facilities with diarrhea, which could reduce the average duration of diarrhea by at least two days.
According to Dr. Delfino Vubil, CryptoT&T Principal Investigator in Mozambique, the study will be carried out in Hospitals or Health Centers in three provinces, namely Maputo, Inhambane and Zambézia, involving around 1,500 children aged 12-23 months who attend health services with symptoms of diarrhea. The participants will be divided into two groups: one that will be treated according to the national guide for handling cases of diarrhea, which will be the control group, and the second intervention group, where the children with Cryptosporidium diarrhea will be treated with nitazoxanide.
“Our aim is to demonstrate that this 'test and treat' strategy reduces the duration of diarrhea and the long-term consequences of the disease. The results of this study could serve to drive changes in the treatment regimen for diarrheal diseases in children under 5 in Mozambique and also at a regional or international level,” said Delfino, adding that the project includes a training component for doctoral graduates in the implementing countries (Ethiopia and Mozambique), providing valuable experience and training as future researchers and beyond.
The project, funded by the European and Developing Countries Clinical Trials Partnership (EDCTP3), is aligned with the United Nations' Sustainable Development Goal 3 and the World Health Organization's initiatives to reduce the burden of diarrheal diseases. The introduction of cryptosporidiosis testing can improve surveillance of this critical pathogen. Effective point-of-care diagnosis and treatment is expected to alleviate diarrhea and reduce long-term complications.
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