Multi-centre Antivenom Trial in Africa

Snakebite can cause life-threatening systemic envenoming that can be treated by rapid administration of safe and effective antivenom. However, there are extremely limited data on the efficacy and safety of antivenoms in sub-Saharan Africa. Antivenoms are entering the market based on animal studies or limited observational human studies with consequent challenges for health policy-makers and clinicians about which antivenoms are best for patients. We aim to conduct a hospital-based multi-country, multi-site Randomised Controlled Trial among adults, adolescents and children over 2 years old to evaluate efficacy and safety of a range of existing and new antivenoms, developing evidence for policy-makers on the optimum antivenoms for their countries. The efficacy of each antivenom in treating acute systemic envenoming will be compared to other locally relevant antivenoms, with a particular focus on the two primary syndromes of coagulopathy and shock. In participants with the rare presentation of neurotoxicity alone, we will estimate overall efficacy and safety rates for each appropriate antivenom. We will enrol approximately 1000 participants with coagulopathy, 1000 participants with shock, and 100 participants with neurotoxicity across ten sites in sub-Saharan Africa, using a novel Personalised RAndomised Controlled Trial (PRACTical) design, with each participant followed for 42 days from randomisation.