An observational study in Snake Envenomation, sponsored by Medecins Sans Frontieres, Netherlands. Recruiting at 1 site in Ethiopia. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Medecins Sans Frontieres, Netherlands · Observational
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.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's planned enrollment of 600 is above the median of 99 across 19 observational studies indexed under Snake Bites.
Browse Snake Bites studies →Medecins Sans Frontieres, Netherlands is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting to Abdurafi health centre in Northwest Ethiopia with snakebite envenoming from June 2025 - June 2026.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients admitted with snakebite envenomation who recieve Premium PANAF antivenom as standard of care and consent for particpation in the study
Safety (Allergic Reactions)
Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system
Time frame: 6 hours
Effectiveness (Correction of Coagulopathy)
Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration
Time frame: 6 hours
Effectiveness (Number of Vials)
Number of doses (vials) needed to reverse the envenomation syndrome
Time frame: 14 days
Effectiveness (Rescue Treatment)
Proportion of patients who require rescue treatment with EchiTab-Plus or SAIMR due to lack of responsiveness to Premium-PANAF
Time frame: 14 days
Effectiveness (Mortality)
Death from any cause within 42 days of treatment with antivenom
Time frame: 42 days
Effectiveness (Patient Specific Function Scale)
Patient-specific Function Scale (PSFS) score
Time frame: 42 days
Effectiveness (Major Bleeding)
Proportion of patients with in-hospital major bleeding (defined according to the International Society on Thrombosis and Haemostasis criteria)
Time frame: 7 days
Effectiveness (Cessation of Bleeding)
Proportion of patients with cessation of bleeding
Time frame: 6 hours
Effectiveness (Serial 20WBCT)
Proportion of patients with reversal of correction of coagulopathy as measured by serial 20min WBCT
Time frame: 14 days
Effectiveness (Blood Transfusion)
Proportion of patients who require blood transfusion during hospitalization
Time frame: 14 days
Effectiveness (Surgical Intervention)
Proportion of patients who require surgical intervention
Time frame: 14 days
Effectiveness (Skin Necrosis)
Mean and median total surface area of full thickness skin necrosis in cm2
Time frame: 48 hours
Effectiveness (Swelling Reduction)
Reduction of swelling extension
Time frame: 6 hours
Effectiveness (Renal Replacement Therapy)
Proportion of participants referred for renal replacement therapy
Time frame: 14 days
Effectiveness (Creatine Kinase)
Peak serum creatine kinase in U/L
Time frame: 14 days
Effectiveness (Need for Ventilation)
Proportion of participants needing mechanical or manual ventilation
Time frame: 48 hours
Safety (Presence of Shock)
Proportion of patients with shock (shock defined as systolic blood pressure \<90mmHg in adults, or age adjusted blood pressure in children)
Time frame: 3 hours
Safety (Need for Adrenaline)
Proportion of patients requiring adrenaline
Time frame: 14 days
Safety (Anaphylaxis)
Proportion of patients experiencing anaphylaxis after antivenom administration
Time frame: 2 hours
Safety (Need for intravenous fluids)
Proportion of patients requiring IV fluids following an allergic reaction
Time frame: 2 hours
Safey (Serum Sickness)
Proportion of patients with confirmed or probable serum sickness
Time frame: 28 days
Safety (Any Other)
Any other (serious) adverse events after enrolment in the study among participants with at least one dose of antivenom delivered
Time frame: 7 days
Plan to share: Yes — All of the individual participant data collected during the study, after de-identification.
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 3 months and ending 5 years following article publication.
Access criteria: Anyone who wishes to access the data in line with MSF data sharing policy: https://www.msf.org/sites/default/files/msf_data_sharing_policy_final_061213.pdf
Data sharing details ↗ · remit.msf.org
No publications or documents are linked to this record.
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Medecins Sans Frontieres, Netherlands