Snake EnvenomationNCT07659002
Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
An observational study of Snake Envenomation, run by Medecins Sans Frontieres, Netherlands at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Snake Envenomation
- How many people
- 600 participants
- Where
- 1 siteEthiopia
- Study dates
- 2 Jun 2025to 1 Sep 2026
- How long will I take part?
- 42 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting to Abdurafi health centre in Northwest Ethiopia with snakebite envenoming from June 2025 - June 2026.
Who may be able to join
- Snakebite envenoming patients who receive Premium-PANAF antivenom
- Patients who have given written informed consent .
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site, 1 recruiting
- Recruiting
Abdurafi Health Center
Ābderafī, Amhara
Site Principal Investigator, +251911210229, ethiopia-medco@oca.msf.org
About this study
Official title: A Prospective Cohort Study of Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
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.
- Conditions
- Snake Envenomation
- Keywords
- prospective observational cohort, Ethiopia, treatment, safety, effectiveness, antivenom, snakebite
- Medical subject headings
- Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Snakebite Envenomation treated with Premium PANAF | Patients admitted with snakebite envenomation who recieve Premium PANAF antivenom as standard of care and consent for particpation in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Allergic Reactions)
Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system
Measured: 6 hours
Effectiveness (Correction of Coagulopathy)
Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration
Measured: 6 hours
Secondary outcomes (20)
Effectiveness (Number of Vials)
Number of doses (vials) needed to reverse the envenomation syndrome
Measured: 14 days
Effectiveness (Rescue Treatment)
Proportion of patients who require rescue treatment with EchiTab-Plus or SAIMR due to lack of responsiveness to Premium-PANAF
Measured: 14 days
Effectiveness (Mortality)
Death from any cause within 42 days of treatment with antivenom
Measured: 42 days
Effectiveness (Patient Specific Function Scale)
Patient-specific Function Scale (PSFS) score
Measured: 42 days
Effectiveness (Major Bleeding)
Proportion of patients with in-hospital major bleeding (defined according to the International Society on Thrombosis and Haemostasis criteria)
Measured: 7 days
Effectiveness (Cessation of Bleeding)
Proportion of patients with cessation of bleeding
Measured: 6 hours
Effectiveness (Serial 20WBCT)
Proportion of patients with reversal of correction of coagulopathy as measured by serial 20min WBCT
Measured: 14 days
Effectiveness (Blood Transfusion)
Proportion of patients who require blood transfusion during hospitalization
Measured: 14 days
Effectiveness (Surgical Intervention)
Proportion of patients who require surgical intervention
Measured: 14 days
Effectiveness (Skin Necrosis)
Mean and median total surface area of full thickness skin necrosis in cm2
Measured: 48 hours
Effectiveness (Swelling Reduction)
Reduction of swelling extension
Measured: 6 hours
Effectiveness (Renal Replacement Therapy)
Proportion of participants referred for renal replacement therapy
Measured: 14 days
Effectiveness (Creatine Kinase)
Peak serum creatine kinase in U/L
Measured: 14 days
Effectiveness (Need for Ventilation)
Proportion of participants needing mechanical or manual ventilation
Measured: 48 hours
Safety (Presence of Shock)
Proportion of patients with shock (shock defined as systolic blood pressure <90mmHg in adults, or age adjusted blood pressure in children)
Measured: 3 hours
Safety (Need for Adrenaline)
Proportion of patients requiring adrenaline
Measured: 14 days
Safety (Anaphylaxis)
Proportion of patients experiencing anaphylaxis after antivenom administration
Measured: 2 hours
Safety (Need for intravenous fluids)
Proportion of patients requiring IV fluids following an allergic reaction
Measured: 2 hours
Safey (Serum Sickness)
Proportion of patients with confirmed or probable serum sickness
Measured: 28 days
Safety (Any Other)
Any other (serious) adverse events after enrolment in the study among participants with at least one dose of antivenom delivered
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start2 Jun 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Snake EnvenomationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 42 Days
Sponsor and investigators
- Lead sponsor
- Medecins Sans Frontieres, Netherlands
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gondar
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659002
- Sponsor's protocol ID
- ID2452-Remit-OCA024-07
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the study, after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
- ClinicalTrials.gov ID
- NCT07659002
- Acronym / sponsor ID
- ID2452-Remit-OCA024-07
- Conditions
- Snake Envenomation
- Keywords
- prospective observational cohort, Ethiopia, treatment, safety, effectiveness, antivenom, snakebite
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medecins Sans Frontieres, NetherlandsUniversity, hospital or other
- Collaborators
- University of Gondar
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 42 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Snakebite Envenomation treated with Premium PANAF | – | –Patients admitted with snakebite envenomation who recieve Premium PANAF antivenom as standard of care and consent for particpation in the study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to Abdurafi health centre in Northwest Ethiopia with snakebite envenoming from June 2025 - June 2026.
Key inclusion criteria (2 listed)
- Snakebite envenoming patients who receive Premium-PANAF antivenom
- Patients who have given written informed consent .
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety (Allergic Reactions)
Time frame: 6 hours
Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system
Effectiveness (Correction of Coagulopathy)
Time frame: 6 hours
Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration
20 secondary outcomes
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
Effectiveness (Creatine Kinase)
Time frame: 14 days
Effectiveness (Need for Ventilation)
Time frame: 48 hours
Safety (Presence of Shock)
Time frame: 3 hours
Safety (Need for Adrenaline)
Time frame: 14 days
Safety (Anaphylaxis)
Time frame: 2 hours
Safety (Need for intravenous fluids)
Time frame: 2 hours
Safey (Serum Sickness)
Time frame: 28 days
Safety (Any Other)
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the study, after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Snake Envenomation, run by Medecins Sans Frontieres, Netherlands at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Allergic Reactions) (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.