DETERMINATION OF OPTIMAL RABIES IMMUNOGLOBULIN (RIG) VOLUME FOR LOCAL WOUND MANAGEMENT OF ANIMAL BITES IN CHILDREN AND ADOLESCENTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The quantity of RIG infiltrated in relation to the size of the   Â
研究概览
简要总结
Rabies is a viral zoonotic disease.It transmits through infected saliva via bites or scratches
from rabid animals (in particular dogs).Rabies is an invariably fatal disease. An unknown number of humans die of rabies every year
worldwide. News media often estimate 40,000 to 60,000 annual human cases worldwide.
India alone reports approximately 20,000 deaths annually.Rabies immune globulin (RIG) is an essential part of postexposure rabies treatment.It
provides protection against the virus during the first 10–14 days after exposure, and before
endogenous neutralizing antibodies are formed in response to vaccination.RIG, that is
injected into and around the virus inoculation sites,which saves lives. One-half of the RIG
should be injected into the bite wounds and the rest intramuscularly,at a different site than
vaccine.This injection is often performed into the gluteal region; a site which except in the
very lean, contains a thick fat layer.RIG,injected at sites other than the wounds,has any
value in neutralizing virus.HRIG is manufactured from non-UK human blood products. The final formulation is a liquid
and the potency of the material is assessed in international units (IU/ml). The maximum dose
is 20IU/kg, adults and children (all ages), and should not be exceeded as it may inhibit the
immune response to rabies vaccine.
WHO Expert Committee’s recommendation was changed from intramuscular administration
to one where ‘as much as possible’ of the calculated dose of RIG was to be injected into and
around the wound.The dose was, and remains, calculated on the basis of body weight,
suggesting that these recommendations have been trapped in their own irrational history.
Recognising that dog bites vary in number, size and location, these recommendations allow
RIG to be diluted in saline to ensure there is sufficient volume to inject into all wounds.
Curiously, where the wound is too small to take the whole dose, it is still stated that the
residue is to be inoculated into a distal site, even though it is accepted that this will not result
in a significant circulation antibody level.
so we are conducting this study to find out the optimal dose of rabies immunoglobulin (RIG) volume for local wound management of animal bites in children and adolescents.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •All the children age between 2 to 18 yrs reporting to animal bite clinic for the first time.
排除标准
- •Children who have already received rabies immunoglobulin in any time in the past.
结局指标
主要结局
The quantity of RIG infiltrated in relation to the size of the   Â
时间窗: ONE YEAR
wound.
时间窗: ONE YEAR
次要结局
- N/A(N/A)
