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临床试验/NCT00811239
NCT00811239已完成1 期

A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus

Hanoi Medical University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2004年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
81
试验地点
1
主要终点
duration of mechanical ventilation

研究概览

简要总结

In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus. Hitherto, these victims have received supportive care only. The aims of this study were to assess the possible efficacy and side effects of a newly produced antivenom.

详细描述

Venomous snakebites constitute a serious health problem in many Asian countries. In Vietnam, the burden of snakebite on the public health stimulated Calmette to conduct original studies at the Vaccine Institute in Saigon over a hundred years ago and to develop the first snake antivenom ever.

In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus, which is the only krait species giving rise to significant morbidity and mortality in the area. Its venom contains toxins which can cause severe neuromuscular blockade but which do not give rise to swelling or necrosis at the site of the bite.

Supportive care is an important part of the management of snakebites, but antivenom administration is the mainstay therapy in the majority of medically significant envenomings. Such specific therapy may dramatically reduce the consequences of the envenomation. In Vietnam, no specific antivenom against B. multicinctus has been available until recently when it has produced for clinical use.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Envenomed by B. multicinctus
  • Showed clinical signs of systemic envenomation (neuromuscular signs)
  • Provided written informed consent (during the year 2006)

排除标准

  • Pregnancy
  • Patients had a known history of intolerance to equine serum

研究组 & 干预措施

control group

Other

As the antivenom was not yet clinically available until 2006, all patients included during the first two years (2004-2005) received supportive therapy only.

干预措施: Supportive Care (Other)

antivenom group

Active Comparator

The patients included during the third year (2006) were treated with antivenom therapy and supportive care.

干预措施: Bungarus multicinctus-candidus Antivenom (Drug)

结局指标

主要结局

duration of mechanical ventilation

时间窗: the length of ICU stay

次要结局

  • clinical course during ICU stay(the length of ICU stay)
  • complications (Ventilator associated pneumonia...)(the length of ICU stay)
  • adverse effects (anaphylaxis, serum sickness...)(the length of ICU stay)
  • hyponatremia, renal and liver function(the length of ICU stay)

研究者

发起方
Hanoi Medical University
申办方类型
Other

研究点 (1)

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