Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Snake Envenomation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ethiopia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Cohort Study of Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
Overview
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.
Primary outcome measures
- Safety (Allergic Reactions) [Time frame: 6 hours]
- Effectiveness (Correction of Coagulopathy) [Time frame: 6 hours]
Secondary outcome measures (12)
- Effectiveness (Number of Vials) [Time frame: 14 days]
- Effectiveness (Rescue Treatment) [Time frame: 14 days]
- Effectiveness (Mortality) [Time frame: 42 days]
- Effectiveness (Patient Specific Function Scale) [Time frame: 42 days]
- Effectiveness (Major Bleeding) [Time frame: 7 days]
- Effectiveness (Cessation of Bleeding) [Time frame: 6 hours]
- Effectiveness (Serial 20WBCT) [Time frame: 14 days]
- Effectiveness (Blood Transfusion) [Time frame: 14 days]
- Effectiveness (Surgical Intervention) [Time frame: 14 days]
- Effectiveness (Skin Necrosis) [Time frame: 48 hours]
- Effectiveness (Swelling Reduction) [Time frame: 6 hours]
- Effectiveness (Renal Replacement Therapy) [Time frame: 14 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ethiopia · 1 center
- Abdurafi Health Center — Ābderafī
Identifiers
NCT: NCT07659002 · ID2452-Remit-OCA024-07