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临床试验/ACTRN12618000788279
ACTRN12618000788279招募中4 期

Safely Preventing Errors and Complications in children aged 6 months to 16 years due to Inappropriate Antibiotic Allergy Labelling by safely completing an antibiotic provocation challenge to confirm or deny the label. (The SPECIAL Study – The Paediatric Arm)

Perth Children's Hospital0 个研究点目标入组 3,000 人开始时间: 2018年5月9日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
3,000

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Diagnosis
盲法
Open (masking not used)

入排标准

年龄范围
6 Months 至 16 Years(—)
性别
All

入选标准

  • Children and young adults, male or female, aged 6 months to 16 years of age (inclusive) who have a self-reported antibiotic allergy who are willing and available for the 2 year follow up in Western Australia.

排除标准

  • Females who are pregnant (Pregnancy tests will be offered to sexually active females and can be performed on the day of challenge)
  • >Families with the inability to give informed consent based on language barriers
  • >Severe cutaneous adverse reactions
  • >Type II-IV allergies (Serum sickness, Stevens-Johnson Syndrome (SJS), Toxic epidermal necrolysis (TEN), Acute interstitial nephritis (AIN), Drug rash eosinophilia syndrome (DRESS), Acute generalised Exanthematous Pustulosis (AGEP), Haemolytic anaemia)

研究者

发起方
Perth Children's Hospital

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