Health Trials

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

ConditionSnake Envenomation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedecins Sans Frontieres, Netherlands

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Snakebite envenoming patients who receive Premium-PANAF antivenom

Patients who have given written informed consent .

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Snakebite Envenomation treated with Premium PANAF

Trial outcomes

Primary outcomes

1

Safety (Allergic Reactions)

Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system

Time frame
6 hours
2

Effectiveness (Correction of Coagulopathy)

Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration

Time frame
6 hours

Secondary outcomes

1

Effectiveness (Number of Vials)

Number of doses (vials) needed to reverse the envenomation syndrome

Time frame
14 days
2

Effectiveness (Rescue Treatment)

Proportion of patients who require rescue treatment with EchiTab-Plus or SAIMR due to lack of responsiveness to Premium-PANAF

Time frame
14 days
3

Effectiveness (Mortality)

Death from any cause within 42 days of treatment with antivenom

Time frame
42 days
4

Effectiveness (Patient Specific Function Scale)

Patient-specific Function Scale (PSFS) score

Time frame
42 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medecins Sans Frontieres, Netherlands

Lead sponsor

University of Gondar, Gondar, Ethiopia

Collaborator

Source ClinicalTrials.gov
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