Abstract
BackgroundIn West Africa, envenoming by saw-scaled or carpet vipers (Echis ocellatus) causes great morbidity and mortality, but there is a crisis in supply of effective and affordable antivenom (ISRCTN01257358).MethodsIn a randomised, double-blind, controlled, non-inferiority trial, “EchiTAb Plus-ICP” (ET-Plus) equine antivenom made by Instituto Clodomiro Picado was compared to “EchiTAb G” (ET-G) ovine antivenom made by MicroPharm, which is the standard of care in Nigeria and was developed from the original EchiTAb-Fab introduced in 1998. Both are caprylic acid purified whole IgG antivenoms. ET-G is monospecific for Echis ocellatus antivenom (initial dose 1 vial) and ET-Plus is polyspecific for E. ocellatus, Naja nigricollis and Bitis arietans (initial dose 3 vials). Both had been screened by pre-clinical and preliminary clinical dose-finding and safety studies. Patients who presented with incoagulable blood, indicative of systemic envenoming by E. ocellatus, were recruited in Kaltungo, north-eastern Nigeria. Those eligible and consenting were randomly allocated with equal probability to receive ET-Plus or ET-G. The primary outcome was permanent restoration of blood coagulability 6 hours after the start of treatment, assessed by a simple whole blood clotting test repeated 6, 12, 18, 24 and 48 hr after treatment. Secondary (safety) outcomes were the incidences of anaphylactic, pyrogenic and late serum sickness-type antivenom reactions.FindingsInitial doses permanently restored blood coagulability at 6 hours in 161/194 (83.0%) of ET-Plus and 156/206 (75.7%) of ET-G treated patients (Relative Risk [RR] 1.10 one-sided 95% CI lower limit 1.01; P = 0.05). ET-Plus caused early reactions on more occasions than did ET-G [50/194 (25.8%) and 39/206 (18.9%) respectively RR (1.36 one-sided 95% CI 1.86 upper limit; P = 0.06). These reactions were classified as severe in 21 (10.8%) and 11 (5.3%) of patients, respectively.ConclusionAt these doses, ET-Plus was slightly more effective but ET-G was slightly safer. Both are recommended for treating E. ocellatus envenoming in Nigeria.Trial RegistrationCurrent Controlled Trials ISRCTN01257358
Highlights
Bites by saw-scaled or carpet vipers (Echis ocellatus) are frequent in the savanna region of West Africa, where agricultural workers and their children are at greatest risk [1,2,3,4,5,6]
At these doses, ET-Plus was slightly more effective but EchiTAb G’’ (ET-G) was slightly safer. Both are recommended for treating E. ocellatus envenoming in Nigeria
Among 646 patients who were ineligible because their blood was coagulable, 74 had been bitten by snake species other than E. ocellatus [night adders (Causus maculatus), burrowing asps (Atractaspis dahomeyensis and A. watsoni) and cobras (Naja nigricollis) identified by examination of the dead snakes brought by these patients] and 572 showed only local or no envenoming
Summary
Bites by saw-scaled or carpet vipers (Echis ocellatus) are frequent in the savanna region of West Africa, where agricultural workers and their children are at greatest risk [1,2,3,4,5,6]. In Nigeria, where untreated case fatality exceeds 10–20%, E. ocellatus causes hundreds of deaths each year [1,18,19]. Trial of Antivenoms in Carpet Viper Envenoming. In West Africa, envenoming by saw-scaled or carpet vipers (Echis ocellatus) causes great morbidity and mortality, but there is a crisis in supply of effective and affordable antivenom (ISRCTN01257358)
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