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临床试验/NCT03326492
NCT03326492已完成不适用

Evaluation of Anti-venoms Serum in Africa (ESAA). Data Collection in Real Life Conditions

Institut Pasteur13 个研究点 分布在 1 个国家目标入组 474 人开始时间: 2019年10月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
474
试验地点
13
主要终点
Short term tolerance of the antivenom serum Inoserp Pan-Africa®

研究概览

简要总结

There is little or no assessment under real-use conditions of the efficacy and the tolerance in the short, medium and long term of the antivenoms currently on the market and used in the treatment of snake bites.

The main objective is to assess the short term tolerance (< 2 hours post-injection) of the antivenom Inoserp Pan-Africa® (temporary market authorization) from Inosan laboratory currently available in Cameroon.

详细描述

Globally, the number of annual envenomings is estimated to be between 420,000 and 1,800,000. In sub-Saharan Africa, the annual number of envenomings is estimated at 315,000, leading to more than 9,000 amputations and about 7,000 deaths.

Snake bites are recognized by many authors as a neglected disease, whose incidence is underestimated or even unknown in several countries of sub-Saharan Africa. Few data are currently available on the morbidity, mortality and economic impact of snake bites.

In Cameroon and particularly in the northern part of the country, where the density of snakes is high, a few studies have been carried out. In 2002, the annual incidence of envenomings was estimated at 200/100 000 inhabitants, of which 85% was due to Echis ocellatus, and the lethality was 23.9% in some centers. The Ministry of Public Health introduced snake bites in 2015 as a priority health problem in the list of diseases being monitored. Thus, a national epidemiological surveillance system, with a weekly count of snake bites, has been implemented. In the first year, the incidence of annual snake bites was 11.4/100,000 inhabitants, representing more than 2,500 bites per year, including 43 deaths and a case fatality rate of up to 6% in some areas. The northern region (Adamaoua, North and Far North regions) (savanna and mixed zone) accounts for 40% of the country's burden and 77% of the deadly burden, while the forest zone accounts for 32% of the burden Morbid disease and 16% of the fatal burden (ministerial source). The monitoring is based on paper registers for bite reporting, supplemented by the sending of pharmacovigilance data by text messages, but this is very little used in current practice. The data collection system in Cameroon could therefore be improved in terms of both completeness and speed of centralizing data.

These estimates are likely to be well below the reality given the non-exhaustive nature of the data collection and the frequent use of traditional practitioners without referral in a hospital structure.

In recent years, FAV-Afrique® produced by Sanofi-Pasteur was the treatment of reference for venomous snake bites in West and Central Africa. It was the most evaluated and the most effective, reducing by a factor 5 to 10 the mortality. This anti-venom serum was polyspecific, containing an antivenom against ten species of snakes: Naja melanoleuca, nigricollis & haje; Dendroaspis polylepis, viridis & jamesoni, Bitis gabonica & arietans; Echis leucogaster & ocellatus.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient over 5 years old (inclusive) visiting at a participating center for a snake bite with or without confirmed envenoming
  • Informed consent to research

排除标准

  • Patient refusal
  • Under 5 year-old
  • Antivenom serum administration before the arrival in the participating center
  • History of severe allergic reactions to antivenom serum

研究组 & 干预措施

Patients bitten by a snake

Any patient over 5 years old going to a participating center for curative care following a snake bite.

Participation to the study does not change usual follow-up of patients. Antivenom serum Inoserp Pan-Africa® injection will be decided according to the clinical evaluation of the patient.

干预措施: Antivenom serum Inoserp Pan-Africa® injection (Drug)

结局指标

主要结局

Short term tolerance of the antivenom serum Inoserp Pan-Africa®

时间窗: 30 months

The short-term tolerance of the antivenom serum Inoserp Pan-Africa® will be assessed by the monitoring of the clinical signs occurence less than 2 hours post-injection

次要结局

  • Medium term tolerance of the antivenom serum Inoserp Pan-Africa®(30 months)
  • Short term efficacy of the antivenom serum Inoserp Pan-Africa®(30 months)
  • Medium term efficacy of the antivenom serum Inoserp Pan-Africa®(30 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (13)

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Evaluation of Anti-venoms Serum in Africa | 临床试验