The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge - An International Multicenter Randomized Control Trial - The PALACE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 12
- 主要终点
- The difference in the proportion of positive oral challenges (i.e. immune-mediated reaction)
研究概览
简要总结
Whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.
详细描述
Patient-reported penicillin allergies result in poor health outcomes for patients and drive inappropriate antibiotic prescribing, antimicrobial resistance and healthcare costs. Our group has internally and externally validated a novel penicillin allergy clinician decision rule (PEN-FAST) that is able to identify low risk penicillin allergies with a negative predictive value of 96% (95%; 94-98%). Therefore, whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients referred to the outpatient allergy clinic for a penicillin allergy history;
- •Willing and able to give consent.
排除标准
- •Patient age is < 18 years;
- •Patients with a PEN-FAST score less than 3
- •Any other illness that, in the investigator's judgement, will substantially increase the risk associated with subject's participation in this study;
- •Patients with history of type A adverse drug reaction, drug-associated anaphylaxis, idiopathic urticaria/anaphylaxis, mastocytosis, serum sickness, blistering skin eruption or acute interstitial nephritis;
- •Patients where the allergy history was not able to be confirmed with patient;
- •Patients on concurrent antihistamine therapy;
- •Patients receiving more than stress dose steroids (i.e. > 50mg QID hydrocortisone [or steroid equivalent]).
结局指标
主要结局
The difference in the proportion of positive oral challenges (i.e. immune-mediated reaction)
时间窗: up to 48H after oral challenge
次要结局
- The proportion of patients with a penicillin allergy who experience an antibiotic associated immune mediated adverse event OR severe adverse drug reaction as per protocol definitions.(Up to 48h after the drug challenge)
- The proportion of patients with a penicillin allergy who experience an antibiotic associated non-immune mediated adverse event.(Up to 48h after the drug challenge)
- Proportion of patient with positive Penicillin Skin Testing(Up to 48h after the drug challenge)
- The proportion of patients that will respect the protocol (protocol compliance)(Up to 48h after the drug challenge)
- Proportion of patients with severe adverse reaction - anaphylaxis/death(Up to 48h after the drug challenge)
- Time from randomization to delabelling(Up to 48h after the drug challenge)
- Feasibility of intervention delivery defined as the proportion of patients randomized to the intervention arm who had the intervention delivered as per protocol. [Intervention to recruitment ratio](Before randomization)
- Proportion of patients referred to the outpatient allergy clinic that are eligible for intervention (i.e randomization) as per protocol [Eligibility to screened ratio](Before randomization)
- Feasibility of recruitment defined as the proportion of patients consenting to participate in the study as per protocol from eligible patients. [Recruitment to eligibility ratio].(Before randomization)
- Proportion of patients with non-immune mediated positive oral provocation(Up to 48h after the drug challenge)
- Number of appointments required for Penicillin delabelling(Up to 48h after the drug challenge)
- Assessment with the Pre-Questionnaire and the 6 months follow-up Questionnaire(Up to 6 months after the drug challenge)
研究者
Ana Copaescu
Physician-Scientist Immunology and Allergy
McGill University Health Centre/Research Institute of the McGill University Health Centre