Snake Envenomation
Conditions
Keywords
prospective observational cohort, Ethiopia, treatment, safety, effectiveness, antivenom, snakebite
Brief summary
Snakebite Envenomation is recognised as a Neglected Tropical Diseases with high lethality in Sub-Saharan Africa. The current syndromic treatment approach is also fraught by supply pipeline constraints and need for cold-chain, thus negatively impacting outcomes in resource limited settings. Despite the lack of clinical outcome data from studies in humans, after a comprehensive risk-benefit assessment, the World Health Organisation (WHO), in May 2023, recommended the use of Premium-PANAF polyvalent snake antivenom that is lyophilised, and therefore does not require cold-chain conditions. Médecins Sans Frontières (MSF) also updated its treatment protocol with Premium PANAF being standard of care since June 2025 at Abdurafi (Midre Genet) Health Centre in north west Ethiopia. Real-world effectiveness by means of Phase IV post marketing studies or pharmacovigilance programmes in countries where it has recently been rolled out is not yet available. This prospective observational cohort study, with a capped sample size of 600 patients, would thus provide much needed evidence on the safety and effectiveness of Premium-PANAF in resource limited settings to help inform national and international treatment guidelines.
Interventions
None listed
Sponsors
Medecins Sans Frontieres, Netherlands
University of Gondar, Gondar, Ethiopia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Snakebite envenoming patients who receive Premium-PANAF antivenom * Patients who have given written informed consent .
Exclusion criteria
* Snakebite envenoming patients who do not receive Premium-PANAF antivenom * Patients referred from other centres who already received other antivenom treatment * Patients who are unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Allergic Reactions) | 6 hours | Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system |
| Effectiveness (Correction of Coagulopathy) | 6 hours | Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness (Number of Vials) | 14 days | Number of doses (vials) needed to reverse the envenomation syndrome |
| Effectiveness (Rescue Treatment) | 14 days | Proportion of patients who require rescue treatment with EchiTab-Plus or SAIMR due to lack of responsiveness to Premium-PANAF |
| Effectiveness (Mortality) | 42 days | Death from any cause within 42 days of treatment with antivenom |
| Effectiveness (Patient Specific Function Scale) | 42 days | Patient-specific Function Scale (PSFS) score |
| Effectiveness (Major Bleeding) | 7 days | Proportion of patients with in-hospital major bleeding (defined according to the International Society on Thrombosis and Haemostasis criteria) |
| Effectiveness (Cessation of Bleeding) | 6 hours | Proportion of patients with cessation of bleeding |
| Effectiveness (Serial 20WBCT) | 14 days | Proportion of patients with reversal of correction of coagulopathy as measured by serial 20min WBCT |
| Effectiveness (Blood Transfusion) | 14 days | Proportion of patients who require blood transfusion during hospitalization |
| Effectiveness (Surgical Intervention) | 14 days | Proportion of patients who require surgical intervention |
| Effectiveness (Skin Necrosis) | 48 hours | Mean and median total surface area of full thickness skin necrosis in cm2 |
| Effectiveness (Swelling Reduction) | 6 hours | Reduction of swelling extension |
| Effectiveness (Renal Replacement Therapy) | 14 days | Proportion of participants referred for renal replacement therapy |
| Effectiveness (Creatine Kinase) | 14 days | Peak serum creatine kinase in U/L |
| Effectiveness (Need for Ventilation) | 48 hours | Proportion of participants needing mechanical or manual ventilation |
| Safety (Presence of Shock) | 3 hours | Proportion of patients with shock (shock defined as systolic blood pressure \<90mmHg in adults, or age adjusted blood pressure in children) |
| Safety (Need for Adrenaline) | 14 days | Proportion of patients requiring adrenaline |
| Safety (Anaphylaxis) | 2 hours | Proportion of patients experiencing anaphylaxis after antivenom administration |
| Safety (Need for intravenous fluids) | 2 hours | Proportion of patients requiring IV fluids following an allergic reaction |
| Safey (Serum Sickness) | 28 days | Proportion of patients with confirmed or probable serum sickness |
| Safety (Any Other) | 7 days | Any other (serious) adverse events after enrolment in the study among participants with at least one dose of antivenom delivered |
Countries
Ethiopia
Outcome results
None listed