Clinical safety of a polyvalent F(ab′)2 equine antivenom in 223 African snake envenomations:: a field trial in Cameroon

A large-scale clinical trial was conducted, according to World Health Organization Good Clinical Practice guidelines, in 7 centres in north Cameroon to determine the safety and efficacy of a polyvalent antivenom composed of purified F(ab')(2). This study included 223 patients presenting clinically with obvious snake bite, predominantly due to Echis ocellatus (viper), the most abundant species in this savannah region. Clinical surveillance was maintained for 5 d in all patients and until the twenty-sixth day in 74% of cases. Two 10 mt ampoules of polyvalent F(ab')(2) equine antivenom (Ipser Africa(TM)) were administered to each patient by intravenous infusion. If necessary, treatment was repeated 1 h after the end of the first infusion, and then with a frequency determined by the patient's clinical condition. Before initiation of antivenom treatment, the main clinical disorders observed on admission were oedema (93.7%) and haemorrhage (4-8.9 %), with a clotting time longer than 30 min in 65.4% of patients. Clinical cure was obtained in 213 patients (96.8%). No amputation was necessary, and the case fatality rate was only 1.3%. On average, 4.6 (+/-3.7) ampoules were administered per patient; 43% of subjects recovered after only a single infusion of 2 ampoules. Early adverse reactions, of varying degrees of severity, were observed in 6.3% of patients. A severe early reaction, anaphylactic shock, was observed in only one patient (0.4%). Serum sickness was observed in another patient. Polyvalent F(ab')(2) equine antivenom given by repeated 20 mt intravenous infusions is a safe and effective treatment for envenomation caused by African vipers.