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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 22, 2026 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07659002
Lead Sponsor Medecins Sans Frontieres, Netherlands
Collaborators: University of Gondar, Gondar, Ethiopia
Conditions
(from sponsor)		 Snake Envenomation
Related terms Snake Bites
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov