The new SEMA ReACT (SEvere MAlaria treatment with Rectal artesunate and Artemisinin-based Combination Therapy [in remote settings]) consortium aims to fill the evidence gap in the use of an intervention used to buy time to seek further care in remote contexts where health facility transfer is not feasible.
The challenge of saving lives: where systems fall apart
A malaria infection can turn into a medical emergency that can kill quickly if left untreated—within 24 hours of symptom onset. In some rural settings, the nearest hospital can be over 6 hours away. For severely ill children unable to swallow medicine orally, artesunate rectal capsules can be administered to buy precious time to make the journey. However, for those who fall ill with malaria in highly isolated settings, a health facility may be entirely out of reach. This can be due to lack of transportation in general, and, in case of flooding during the rainy season, challenging infrastructure, low availability of services, security concerns or cost.
In response to recent studies on pre-referral treatment with artesunate rectal capsules, the World Health Organization (WHO) has registered concern that in instances where the recommended follow-up measures, including transfer to a health facility, IV treatment and proper discharge planning, are not followed, that patients may suffer poor outcomes. However, there is currently little guidance based on real-world evidence available to inform front-line health workers on what to do when confronted with no timely options to transfer severely ill patients to higher level health centers.
This Phase IV observational study seeks to optimize pre-referral care of patients with severe malaria, in the context of these real-life challenges, by implementing and evaluating a novel approach to the management of severe malaria—one that may be used if timely transfer to a health facility is not feasible. Artesunate rectal capsules will be administered at the community level, and clinical outcomes and potential signs of drug resistance will be evaluated. Then, the intervention will be followed-up with the administration of oral artemisinin-based combination therapies (ACTs) once patients are well enough to swallow medicine. The approach represents an innovative effort to respond to the real challenges faced by those living in highly isolated rural settings, including the inability to reach a health facility in time to receive care.
Addressing the needs of rural patients
“The severe form of malaria is the nightmare that every home in Africa dreads,” says Christine Manyando, Head of the Public Health Department at the Tropical Diseases Research Centre in Zambia. “It can hit without warning and affects children primarily. Home grown and locally led solutions, such as the one this study is investigating, aim to allow for seamless implementation in the communities most affected by malaria, and long-term sustainability of lifesaving strategies.”
“New tools to combat malaria are only useful if they are integrated in healthcare policies and practices and make a real-life difference for those who need them,” says Jean-Pierre Van geertruyden, Professor of Global Health at the University of Antwerp in Belgium. “This implementation project is an indispensable milestone as it will assess—and hopefully help to overcome—barriers to implementing and maintaining severe malaria case management strategies to a high standard.”
“People living in poverty in very isolated rural settings are amongst the most at risk to malaria worldwide,” said George Jagoe, EVP for access at Medicines for Malaria Venture. “By exploring pragmatic ways to use today’s malaria medicines for optimal outcomes when severe malaria occurs in these difficult settings, this study may contribute to better algorithms for rural management of severe malaria in the future.”
The consortium is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Swiss State Secretariat for Education, Research and Innovation (SERI). It is led scientifically by the Tropical Diseases Research Centre in Zambia, and management and coordination is provided by the Global Health Institute at the University of Antwerp in Belgium. The social science component of the study is led by The University of Kinshasa in the Democratic Republic of Congo. The National Institute of Medical Research in Tanzania leads molecular analysis and Medicines for Malaria Venture leads the communication and dissemination of data generated by the study.
In addition to the consortium partners, the National Malaria Elimination Centre in Zambia and the National Malaria Control Programmes in Democratic Republic of Congo and in Tanzania will play key roles in the study, ensuring readiness of health workers, training and managing logistics in the local districts where the study will be conducted.
