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

NCT07659002 | Recruiting

• 1 other identifier: ID2452-Remit-OCA024-07
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Snake Envenomation

Keywords

prospective observational cohort; Ethiopia; treatment; safety; effectiveness; antivenom; snakebite

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• Effectiveness (Number of Vials)

  14 days

• Effectiveness (Rescue Treatment)

  14 days

• Effectiveness (Mortality)

  42 days

• Effectiveness (Patient Specific Function Scale)

  42 days

• Effectiveness (Major Bleeding)

  7 days

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Snakebite envenoming patients who receive Premium-PANAF antivenom
• Patients who have given written informed consent .

You may not qualify if:

• 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

Sponsors & Collaborators

• Medecins Sans Frontieres, Netherlands: lead
• University of Gondar, Gondar, Ethiopia: collaborator

Study Sites (1)

Abdurafi Health Center

Ābderafī, Amhara, Ethiopia

RECRUITING

MeSH Terms

Conditions

Snake Bites

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 42 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 22, 2026
• Study Start: June 2, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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

Locations

ET (1)