RecruitingNCT07659002

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

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


Sponsor

Medecins Sans Frontieres, Netherlands

Enrollment

600 participants

Start Date

Jun 2, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with snake envenomation. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Abdurafi Health Center

Ābderafī, Amhara, Ethiopia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07659002


Related Trials