Project Lead(s): Jeffrey Pernica
Diarrhoeal disease is the second leading direct cause of death of young children in the world.
It had previously been assumed that most episodes of non-bloody diarrhoea in children were caused by viruses, for which we have no treatment. However, recent studies conducted in different low- and middle-income countries have shown that many children with non-bloody diarrhoea presenting to hospital in resource-limited settings actually have treatable bacterial or protozoan infections.
If children with severe gastroenteritis had rapid testing done at the time of hospitalization, those with treatable infections could be given specific antimicrobials, potentially preventing many deaths and developmental problems.
Many scientists are developing easier, faster and cheaper diagnostic tests to identify the precise cause of childhood gastroenteritis, but no one has yet determined exactly what benefits these tests will produce when integrated into routine clinical care.
Implemented in Botswana, the project was a pilot, randomized clinical trial to assess the benefit of using novel tests to rapidly identify pathogens in children admitted to hospital with diarrhoeal disease, permitting the timely administration of targeted antimicrobial therapy.
This was the first research conducted in Sub-Saharan Africa that demonstrated that regular, comprehensive, diagnostic testing for childhood gastroenteritis was feasible, with potentially major clinical ramifications.
It was also the first example of a properly conducted randomized clinical trial examining the utility of rapid molecular diagnostics to aid the management of acute diarrhoeal disease in children living in a low-to middle-income country.
The use of rapid molecular testing led to a drop of 58% in the odds of recurrent diarrhoea within the 60-day follow-up period, compared to standard treatment. Furthermore, rapid diagnostic testing was associated with an increase of 0.20 in adjusted age-standardized weight (about 250 g for a 10-kg infant) and 0.30 in adjusted age-standardized height (about 0.67 cm for a one-year old infant) at 60 days.
Importantly, the research lays the necessary groundwork for a follow-up, multi-centre trial.
Knowledge has been widely disseminated through publications.
This pilot trial buttressed pre-existing efforts to conduct both gastroenteritis and rotavirus surveillance in Botswana and simultaneously helped establish partnerships with large organizations with an interest in health in Botswana (including the Botswana Ministry of Health and the World Health Organization).
It has also facilitated the development of relationships with corporate entities such as BioGaia S.A., who provided probiotic formulations, and BioMerieux, one of the world’s leading diagnostics manufacturers. This project has also cemented the working relationship between McMaster University and the Botswana-UPenn Partnership, as well as Copan Italia S.A.