ACTRN12619000029190招募中未知
Safely Preventing Errors and Complications due to Inappropriate Allergy Labelling in Adults with a self-reported drug allergy using a drug challenge to confirm or refute allergy label: The SPECIAL Study - Adult Arm
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 768
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
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients (male or female), 16 years and above, presenting as medical or surgical inpatients with a self-reported allergy to beta lactam and/or sulphonamide antibiotics. Clinical examination will determine whether the patient with a disease state, for example a chronic medical condition, is well enough to undergo allergy testing. Any acute condition that necessitated admission will be resolved before allergy testing.
- •Self-reported Antibiotic Allergy Label (AAL)
- •Allergy to any beta-lactam, or allergy to any beta lactam and/or an allergy to one of the following: sulphonamide, macrolide or quinolone antibiotic
- •Reported reaction to an intravenous or oral antibiotic
- •Age >16 years
排除标准
- •Participants unable to give written informed consent
- •A history of severe cutaneous adverse reactions
- •Type II-IV reactions according to the ASCIA Criteria: 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, Drug-induced liver injury (DILI).
- •Participants with clinically established intolerances or allergy to an antibiotic.
- •Females who are pregnant
- •Antihistamine intake within 2 days prior to the scheduled challenge (including medications whose primary use is not as antihistamine but which are known to interact with histamine receptors). Daily antihistamine intake required for management of chronic disease, e.g. chronic idiopathic urticaria.
- •Immunosuppressive treatment at the time of testing
- •Patients on beta-blocker medication
- •A relevant medical contraindication to testing
研究者
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