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.
研究概览
地位
条件
研究类型
注册 (估计的)
联系人和位置
学习地点
-
-
Amhara
-
Ābderafī、Amhara、埃塞俄比亚
- 招聘中
- Abdurafi Health Center
-
接触：
- Site Principal Investigator
- 电话号码：+251911210229
- 邮箱：ethiopia-medco@oca.msf.org
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety (Allergic Reactions)
大体时间：6 hours
|
Proportion of patients with severe allergic reactions within 6 hours of antivenom administration according to the Brown grading system
|
6 hours
|
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Effectiveness (Correction of Coagulopathy)
大体时间：6 hours
|
Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration
|
6 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effectiveness (Number of Vials)
大体时间：14 days
|
Number of doses (vials) needed to reverse the envenomation syndrome
|
14 days
|
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Effectiveness (Rescue Treatment)
大体时间：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)
大体时间：42 days
|
Death from any cause within 42 days of treatment with antivenom
|
42 days
|
|
Effectiveness (Patient Specific Function Scale)
大体时间：42 days
|
Patient-specific Function Scale (PSFS) score
|
42 days
|
|
Effectiveness (Major Bleeding)
大体时间：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)
大体时间：6 hours
|
Proportion of patients with cessation of bleeding
|
6 hours
|
|
Effectiveness (Serial 20WBCT)
大体时间：14 days
|
Proportion of patients with reversal of correction of coagulopathy as measured by serial 20min WBCT
|
14 days
|
|
Effectiveness (Blood Transfusion)
大体时间：14 days
|
Proportion of patients who require blood transfusion during hospitalization
|
14 days
|
|
Effectiveness (Surgical Intervention)
大体时间：14 days
|
Proportion of patients who require surgical intervention
|
14 days
|
|
Effectiveness (Skin Necrosis)
大体时间：48 hours
|
Mean and median total surface area of full thickness skin necrosis in cm2
|
48 hours
|
|
Effectiveness (Swelling Reduction)
大体时间：6 hours
|
Reduction of swelling extension
|
6 hours
|
|
Effectiveness (Renal Replacement Therapy)
大体时间：14 days
|
Proportion of participants referred for renal replacement therapy
|
14 days
|
|
Effectiveness (Creatine Kinase)
大体时间：14 days
|
Peak serum creatine kinase in U/L
|
14 days
|
|
Effectiveness (Need for Ventilation)
大体时间：48 hours
|
Proportion of participants needing mechanical or manual ventilation
|
48 hours
|
|
Safety (Presence of Shock)
大体时间：3 hours
|
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)
大体时间：14 days
|
Proportion of patients requiring adrenaline
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14 days
|
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Safety (Anaphylaxis)
大体时间：2 hours
|
Proportion of patients experiencing anaphylaxis after antivenom administration
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2 hours
|
|
Safety (Need for intravenous fluids)
大体时间：2 hours
|
Proportion of patients requiring IV fluids following an allergic reaction
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2 hours
|
|
Safey (Serum Sickness)
大体时间：28 days
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Proportion of patients with confirmed or probable serum sickness
|
28 days
|
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Safety (Any Other)
大体时间：7 days
|
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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ID2452-Remit-OCA024-07
计划个人参与者数据 (IPD)
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IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
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- 国际碳纤维联合会
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