Other organisations recorded by Europe PMCBayero University Kano · IND George Oluoch 234137 · KEMRI-Wellcome Trust Research Programme · Kwame Nkrumah University of Science and Technology · University College London · University of Newcastle, Australia · World Health Organization, SwitzerlandThese are researcher affiliations; the award is counted once under the primary recipient above.
Funding£13.7M
PeriodFeb 2024 — Feb 2029
In plain English
AI plain-English summary
A hospital-based trial across multiple African countries will directly compare existing and new antivenoms head-to-head in patients suffering from snakebite. This matters because sub-Saharan Africa has almost no reliable data on which antivenoms actually work and are safe. Currently, antivenoms enter the market based only on animal studies or small, uncontrolled human observations, leaving health policymakers and clinicians to guess which products to use. Without evidence, patients may receive ineffective or unsafe treatments. If this trial succeeds, it will produce the first robust evidence on antivenom efficacy for the two most common life-threatening syndromes—coagulopathy and shock—as well as for the rarer presentation of neurotoxicity. Policymakers in each country could then select the best antivenom for their population, replacing guesswork with data. For patients, this means a higher chance of receiving a treatment that actually stops the venom’s effects, reducing death and disability from snakebite across the region.
View original technical description
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.
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