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

15. juni 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

600

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Etiopia
    • Amhara
      • Ābderafī, Amhara, Etiopia
        • Rekruttering
        • Abdurafi Health Center
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Safety (Allergic Reactions)
Tidsramme: 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)
Tidsramme: 6 hours
Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration
6 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Effectiveness (Number of Vials)
Tidsramme: 14 days
Number of doses (vials) needed to reverse the envenomation syndrome
14 days
Effectiveness (Rescue Treatment)
Tidsramme: 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)
Tidsramme: 42 days
Death from any cause within 42 days of treatment with antivenom
42 days
Effectiveness (Patient Specific Function Scale)
Tidsramme: 42 days
Patient-specific Function Scale (PSFS) score
42 days
Effectiveness (Major Bleeding)
Tidsramme: 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)
Tidsramme: 6 hours
Proportion of patients with cessation of bleeding
6 hours
Effectiveness (Serial 20WBCT)
Tidsramme: 14 days
Proportion of patients with reversal of correction of coagulopathy as measured by serial 20min WBCT
14 days
Effectiveness (Blood Transfusion)
Tidsramme: 14 days
Proportion of patients who require blood transfusion during hospitalization
14 days
Effectiveness (Surgical Intervention)
Tidsramme: 14 days
Proportion of patients who require surgical intervention
14 days
Effectiveness (Skin Necrosis)
Tidsramme: 48 hours
Mean and median total surface area of full thickness skin necrosis in cm2
48 hours
Effectiveness (Swelling Reduction)
Tidsramme: 6 hours
Reduction of swelling extension
6 hours
Effectiveness (Renal Replacement Therapy)
Tidsramme: 14 days
Proportion of participants referred for renal replacement therapy
14 days
Effectiveness (Creatine Kinase)
Tidsramme: 14 days
Peak serum creatine kinase in U/L
14 days
Effectiveness (Need for Ventilation)
Tidsramme: 48 hours
Proportion of participants needing mechanical or manual ventilation
48 hours
Safety (Presence of Shock)
Tidsramme: 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)
Tidsramme: 14 days
Proportion of patients requiring adrenaline
14 days
Safety (Anaphylaxis)
Tidsramme: 2 hours
Proportion of patients experiencing anaphylaxis after antivenom administration
2 hours
Safety (Need for intravenous fluids)
Tidsramme: 2 hours
Proportion of patients requiring IV fluids following an allergic reaction
2 hours
Safey (Serum Sickness)
Tidsramme: 28 days
Proportion of patients with confirmed or probable serum sickness
28 days
Safety (Any Other)
Tidsramme: 7 days
Any other (serious) adverse events after enrolment in the study among participants with at least one dose of antivenom delivered
7 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medecins Sans Frontieres, Netherlands

Samarbeidspartnere

University of Gondar, Gondar, Ethiopia

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. juni 2025

Primær fullføring (Antatt)

1. august 2026

Studiet fullført (Antatt)

1. september 2026

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

15. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ID2452-Remit-OCA024-07

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

All of the individual participant data collected during the study, after de-identification.

IPD-delingstidsramme

Beginning 3 months and ending 5 years following article publication.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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