Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
Recruiting now
Conditions studied: Snake Envenomation
In brief
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.
Key facts
- Study ID
- NCT07659002
- Run by
- Medecins Sans Frontieres, Netherlands
- People needed
- 600
- Starts
- 2025-06-02
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-06-22
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Abdurafi Health Center — Ābderafī, Amhara, Ethiopia (enrolling)
Full record on ClinicalTrials.gov
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