2025-520888-41-00尚未招募4 期
PROlonged versus Single dose in PEnicillin oral Challenge Testing double-blind parallel randomized placebo cOntrolled tRial – PROSPECTOR-2 Study
Gentofte Hospital, Austin Health2 个研究点 分布在 2 个国家目标入组 160 人开始时间: 2025年10月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Positive oral challenge (i.e. immune mediated reaction up to and including day 7 following the first test dose, number and percentage of participants), as adjudged by independent blinded panel
研究概览
简要总结
Evaluate the efficacy of prolonged oral penicillin challenge (5 days) over single dose penicillin challenge for ascertainment of true penicillin allergy (i.e. immune mediated allergy).
研究设计
- 分配方式
- Randomized
- 主要目的
- Prospector-2
- 盲法
- Double (Analyst, Investigator, Carer, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients referred to the outpatient allergy clinic or inpatient allergy service (with a non-infective diagnosis) for a penicillin allergy history (i.e. amoxicillin or penicillin unspecified)
- •Adult patients with an immune-mediated penicillin allergy history:
- •Delayed phenotype (> 6 hours post dose)
- •Or unknown timing
- •Tolerated first dose of an oral amoxicillin challenge
- •Willing and able to give consent
- •Willing and able to undergo telehealth or in clinic review post challenge
- •Outpatients who are not currently receiving, or are not likely to receive, beta-lactam antibiotic therapy during the 14-day study period.
排除标准
- •Patient age is < 18 years
- •Any other illness that, in the investigator’s judgement, will substantially increase the risk associated with subject’s participation in this study
- •Stevens-Johnson Syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms or Acute Generalized Exanthematous Pustulosis or Toxic Epidermal Necrolysis to penicillin’s or aminocephalosporins
- •Concurrent use of antihistamines or systemic steroid therapy (> 10 mg daily)
结局指标
主要结局
Positive oral challenge (i.e. immune mediated reaction up to and including day 7 following the first test dose, number and percentage of participants), as adjudged by independent blinded panel
Positive oral challenge (i.e. immune mediated reaction up to and including day 7 following the first test dose, number and percentage of participants), as adjudged by independent blinded panel
次要结局
- Positive oral challenge (i.e. immune mediated reaction up to and including day 14 following the first test dose, number and percentage of participants), as adjudged by independent blinded panel
- Non-inferiority of single dose challenge to prolonged challenge (risk difference with two-sided 95% confidence interval using 10% as clinically relevant non-inferiority margin)
- Time to positive oral challenge
- Quality of life (measured by Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) at day 0 and 90
研究者
Lene Heise Garvey
Scientific
Gentofte Hospital
研究点 (2)
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