A Prospective Cohort Study of Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Safety (Allergic Reactions)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Snakebite envenoming patients who receive Premium-PANAF antivenom
- •Patients who have given written informed consent .
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Safety (Allergic Reactions)
时间窗: 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)
时间窗: 6 hours
Correction of coagulopathy as measured by the 20-minute whole blood clotting test at 6 hours after antivenom administration
次要结局
- Effectiveness (Number of Vials)(14 days)
- Effectiveness (Rescue Treatment)(14 days)
- Effectiveness (Mortality)(42 days)
- Effectiveness (Patient Specific Function Scale)(42 days)
- Effectiveness (Major Bleeding)(7 days)
- Effectiveness (Cessation of Bleeding)(6 hours)
- Effectiveness (Serial 20WBCT)(14 days)
- Effectiveness (Blood Transfusion)(14 days)
- Effectiveness (Surgical Intervention)(14 days)
- Effectiveness (Skin Necrosis)(48 hours)
- Effectiveness (Swelling Reduction)(6 hours)
- Effectiveness (Renal Replacement Therapy)(14 days)
- Effectiveness (Creatine Kinase)(14 days)
- Effectiveness (Need for Ventilation)(48 hours)
- Safety (Presence of Shock)(3 hours)
- Safety (Need for Adrenaline)(14 days)
- Safety (Anaphylaxis)(2 hours)
- Safety (Need for intravenous fluids)(2 hours)
- Safey (Serum Sickness)(28 days)
- Safety (Any Other)(7 days)