Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Amhara
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Ābderafī, Amhara, 에티오피아
- 모병
- Abdurafi Health Center
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연락하다:
- Site Principal Investigator
- 전화번호: +251911210229
- 이메일: ethiopia-medco@oca.msf.org
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety (Allergic Reactions)
기간: 6 hours
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Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system
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6 hours
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Effectiveness (Correction of Coagulopathy)
기간: 6 hours
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Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration
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6 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Effectiveness (Number of Vials)
기간: 14 days
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Number of doses (vials) needed to reverse the envenomation syndrome
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14 days
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Effectiveness (Rescue Treatment)
기간: 14 days
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Proportion of patients who require rescue treatment with EchiTab-Plus or SAIMR due to lack of responsiveness to Premium-PANAF
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14 days
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Effectiveness (Mortality)
기간: 42 days
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Death from any cause within 42 days of treatment with antivenom
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42 days
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Effectiveness (Patient Specific Function Scale)
기간: 42 days
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Patient-specific Function Scale (PSFS) score
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42 days
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Effectiveness (Major Bleeding)
기간: 7 days
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Proportion of patients with in-hospital major bleeding (defined according to the International Society on Thrombosis and Haemostasis criteria)
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7 days
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Effectiveness (Cessation of Bleeding)
기간: 6 hours
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Proportion of patients with cessation of bleeding
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6 hours
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Effectiveness (Serial 20WBCT)
기간: 14 days
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Proportion of patients with reversal of correction of coagulopathy as measured by serial 20min WBCT
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14 days
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Effectiveness (Blood Transfusion)
기간: 14 days
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Proportion of patients who require blood transfusion during hospitalization
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14 days
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Effectiveness (Surgical Intervention)
기간: 14 days
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Proportion of patients who require surgical intervention
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14 days
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Effectiveness (Skin Necrosis)
기간: 48 hours
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Mean and median total surface area of full thickness skin necrosis in cm2
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48 hours
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Effectiveness (Swelling Reduction)
기간: 6 hours
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Reduction of swelling extension
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6 hours
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Effectiveness (Renal Replacement Therapy)
기간: 14 days
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Proportion of participants referred for renal replacement therapy
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14 days
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Effectiveness (Creatine Kinase)
기간: 14 days
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Peak serum creatine kinase in U/L
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14 days
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Effectiveness (Need for Ventilation)
기간: 48 hours
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Proportion of participants needing mechanical or manual ventilation
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48 hours
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Safety (Presence of Shock)
기간: 3 hours
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Proportion of patients with shock (shock defined as systolic blood pressure <90mmHg in adults, or age adjusted blood pressure in children)
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3 hours
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Safety (Need for Adrenaline)
기간: 14 days
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Proportion of patients requiring adrenaline
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14 days
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Safety (Anaphylaxis)
기간: 2 hours
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Proportion of patients experiencing anaphylaxis after antivenom administration
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2 hours
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Safety (Need for intravenous fluids)
기간: 2 hours
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Proportion of patients requiring IV fluids following an allergic reaction
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2 hours
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Safey (Serum Sickness)
기간: 28 days
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Proportion of patients with confirmed or probable serum sickness
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28 days
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Safety (Any Other)
기간: 7 days
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Any other (serious) adverse events after enrolment in the study among participants with at least one dose of antivenom delivered
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7 days
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ID2452-Remit-OCA024-07
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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