Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
15 juni 2026 uppdaterad av: Medecins Sans Frontieres, Netherlands
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.
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Observationell
Inskrivning (Beräknad)
600
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Amhara
-
Ābderafī, Amhara, Etiopien
- Rekrytering
- Abdurafi Health Center
-
Kontakt:
- Site Principal Investigator
- Telefonnummer: +251911210229
- E-post: ethiopia-medco@oca.msf.org
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients presenting to Abdurafi health centre in Northwest Ethiopia with snakebite envenoming from June 2025 - June 2026.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Safety (Allergic Reactions)
Tidsram: 6 hours
|
Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system
|
6 hours
|
|
Effectiveness (Correction of Coagulopathy)
Tidsram: 6 hours
|
Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration
|
6 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Effectiveness (Number of Vials)
Tidsram: 14 days
|
Number of doses (vials) needed to reverse the envenomation syndrome
|
14 days
|
|
Effectiveness (Rescue Treatment)
Tidsram: 14 days
|
Proportion of patients who require rescue treatment with EchiTab-Plus or SAIMR due to lack of responsiveness to Premium-PANAF
|
14 days
|
|
Effectiveness (Mortality)
Tidsram: 42 days
|
Death from any cause within 42 days of treatment with antivenom
|
42 days
|
|
Effectiveness (Patient Specific Function Scale)
Tidsram: 42 days
|
Patient-specific Function Scale (PSFS) score
|
42 days
|
|
Effectiveness (Major Bleeding)
Tidsram: 7 days
|
Proportion of patients with in-hospital major bleeding (defined according to the International Society on Thrombosis and Haemostasis criteria)
|
7 days
|
|
Effectiveness (Cessation of Bleeding)
Tidsram: 6 hours
|
Proportion of patients with cessation of bleeding
|
6 hours
|
|
Effectiveness (Serial 20WBCT)
Tidsram: 14 days
|
Proportion of patients with reversal of correction of coagulopathy as measured by serial 20min WBCT
|
14 days
|
|
Effectiveness (Blood Transfusion)
Tidsram: 14 days
|
Proportion of patients who require blood transfusion during hospitalization
|
14 days
|
|
Effectiveness (Surgical Intervention)
Tidsram: 14 days
|
Proportion of patients who require surgical intervention
|
14 days
|
|
Effectiveness (Skin Necrosis)
Tidsram: 48 hours
|
Mean and median total surface area of full thickness skin necrosis in cm2
|
48 hours
|
|
Effectiveness (Swelling Reduction)
Tidsram: 6 hours
|
Reduction of swelling extension
|
6 hours
|
|
Effectiveness (Renal Replacement Therapy)
Tidsram: 14 days
|
Proportion of participants referred for renal replacement therapy
|
14 days
|
|
Effectiveness (Creatine Kinase)
Tidsram: 14 days
|
Peak serum creatine kinase in U/L
|
14 days
|
|
Effectiveness (Need for Ventilation)
Tidsram: 48 hours
|
Proportion of participants needing mechanical or manual ventilation
|
48 hours
|
|
Safety (Presence of Shock)
Tidsram: 3 hours
|
Proportion of patients with shock (shock defined as systolic blood pressure <90mmHg in adults, or age adjusted blood pressure in children)
|
3 hours
|
|
Safety (Need for Adrenaline)
Tidsram: 14 days
|
Proportion of patients requiring adrenaline
|
14 days
|
|
Safety (Anaphylaxis)
Tidsram: 2 hours
|
Proportion of patients experiencing anaphylaxis after antivenom administration
|
2 hours
|
|
Safety (Need for intravenous fluids)
Tidsram: 2 hours
|
Proportion of patients requiring IV fluids following an allergic reaction
|
2 hours
|
|
Safey (Serum Sickness)
Tidsram: 28 days
|
Proportion of patients with confirmed or probable serum sickness
|
28 days
|
|
Safety (Any Other)
Tidsram: 7 days
|
Any other (serious) adverse events after enrolment in the study among participants with at least one dose of antivenom delivered
|
7 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
2 juni 2025
Primärt slutförande (Beräknad)
1 augusti 2026
Avslutad studie (Beräknad)
1 september 2026
Studieregistreringsdatum
Först inskickad
21 maj 2026
Först inskickad som uppfyllde QC-kriterierna
15 juni 2026
Första postat (Faktisk)
22 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ID2452-Remit-OCA024-07
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
All of the individual participant data collected during the study, after de-identification.
Tidsram för IPD-delning
Beginning 3 months and ending 5 years following article publication.
Kriterier för IPD Sharing Access
Anyone who wishes to access the data in line with MSF data sharing policy: https://www.msf.org/sites/default/files/msf_data_sharing_policy_final_061213.pdf
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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