Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,356
- 主要终点
- Analysis of genetic polymorphisms predictive of risk of beta-lactam immediate allergy
研究概览
简要总结
Beta-lactam antibiotics include penicillin and cephalosporins and are among the most prescribed antibiotics. This category of drugs is the most involved in immediate allergic manifestations with 2% reactions in treated subjects and a fatal outcome in 1/50000 treatments. Reactions are IgE-mediated and have a considerable but unknown genetic origin, revealed by studies in groups of different ethnical origins in the same geographical region. There are also some families with a high frequency of allergic reactions without identified Mendelian inheritance.
The purpose of this study is to identify predictive risk factors associated to immediate allergic reactions against beta-lactam antibiotics with a pangenomic approach.
A secondary purpose is to identify rare predictive factors with homozygosity mapping and exome sequencing in various families with high risk of allergy to beta-lactam antibiotics.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Allergy group: Immediate allergic reaction (less than 2 hours after drug administration) to an antibiotic of penicillin or cephalosporin groups
- •Allergy group: Positive skin test (intradermal test) with a non-irritant dilution of antibiotic of penicillin or cephalosporin groups
排除标准
- •Refusal of participation
结局指标
主要结局
Analysis of genetic polymorphisms predictive of risk of beta-lactam immediate allergy
时间窗: day 0
Common (\>10%) or rare (1-10%) genetic polymorphisms in patients with beta-lactam immediate allergy
次要结局
- Reactivity to skin test(day 0)
- Severity of allergic reaction(day 0)
- Analysis of allelic homozygosity linked to allergen response, in more than 2 allergic individuals of the same family(day 0)
- Serum concentration of specific IgE(day 0)