Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia

A Prospective Cohort Study of Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia

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.

Study Overview

• Status: Recruiting
• Conditions: Snake Envenomation

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• Ethiopia
  • Amhara
    • Ābderafī, Amhara, Ethiopia
      • Recruiting
      • Abdurafi Health Center
      • Contact: Site Principal Investigator; Phone Number: +251911210229; Email: ethiopia-medco@oca.msf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to Abdurafi health centre in Northwest Ethiopia with snakebite envenoming from June 2025 - June 2026.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Snakebite Envenomation treated with Premium PANAF; Patients admitted with snakebite envenomation who recieve Premium PANAF antivenom as standard of care and consent for particpation in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety (Allergic Reactions)	Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system	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	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness (Number of Vials)	Number of doses (vials) needed to reverse the envenomation syndrome	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	14 days
Effectiveness (Mortality)	Death from any cause within 42 days of treatment with antivenom	42 days
Effectiveness (Patient Specific Function Scale)	Patient-specific Function Scale (PSFS) score	42 days
Effectiveness (Major Bleeding)	Proportion of patients with in-hospital major bleeding (defined according to the International Society on Thrombosis and Haemostasis criteria)	7 days
Effectiveness (Cessation of Bleeding)	Proportion of patients with cessation of bleeding	6 hours
Effectiveness (Serial 20WBCT)	Proportion of patients with reversal of correction of coagulopathy as measured by serial 20min WBCT	14 days
Effectiveness (Blood Transfusion)	Proportion of patients who require blood transfusion during hospitalization	14 days
Effectiveness (Surgical Intervention)	Proportion of patients who require surgical intervention	14 days
Effectiveness (Skin Necrosis)	Mean and median total surface area of full thickness skin necrosis in cm2	48 hours
Effectiveness (Swelling Reduction)	Reduction of swelling extension	6 hours
Effectiveness (Renal Replacement Therapy)	Proportion of participants referred for renal replacement therapy	14 days
Effectiveness (Creatine Kinase)	Peak serum creatine kinase in U/L	14 days
Effectiveness (Need for Ventilation)	Proportion of participants needing mechanical or manual ventilation	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)	3 hours
Safety (Need for Adrenaline)	Proportion of patients requiring adrenaline	14 days
Safety (Anaphylaxis)	Proportion of patients experiencing anaphylaxis after antivenom administration	2 hours
Safety (Need for intravenous fluids)	Proportion of patients requiring IV fluids following an allergic reaction	2 hours
Safey (Serum Sickness)	Proportion of patients with confirmed or probable serum sickness	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	7 days

Collaborators and Investigators

• Sponsor: Medecins Sans Frontieres, Netherlands
• Collaborators: University of Gondar, Gondar, Ethiopia

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: treatment; safety; effectiveness; antivenom; Ethiopia; snakebite; prospective observational cohort
• Additional Relevant MeSH Terms: Wounds and Injuries; Chemically-Induced Disorders; Poisoning; Bites and Stings; Snake Bites
• Other Study ID Numbers: ID2452-Remit-OCA024-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the study, after de-identification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No