跳至主要内容
临床试验/CTRI/2021/01/030409
CTRI/2021/01/030409尚未招募不适用

DETERMINATION OF OPTIMAL RABIES IMMUNOGLOBULIN (RIG) VOLUME FOR LOCAL WOUND MANAGEMENT OF ANIMAL BITES IN CHILDREN AND ADOLESCENTS

Department of Pediatrics Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月18日最近更新:

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)

研究者

发起方
Department of Pediatrics Maulana Azad Medical College
申办方类型
Government medical college

研究点 (1)

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