Oral Beta-lactam Drug Reintroduction Protocol, Without Previous Skin Tests, in Children Under 16 Years of Age With a Clinical History That is Not Suggestive of Immunoglobulin E (IgE)-Mediated Anaphylaxis or Toxidermia to Beta-lactams.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction
研究概览
简要总结
The purpose of this study is to establish the rationale for the practice of performing an oral reintroduction test without previous skin tests in children at low risk of IgE-mediated reaction or drug-induced toxidermia, and to confirm the criteria for a drug reintroduction test could be performed without previous skin tests, without subsequent risk of reaction for the child. The primary endpoint will be the risk of a severe IgE-mediated or delayed hypersensitivity reaction in children who received beta-lactam drug reintroduction protocol prior to skin testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children under 16 years of age coming for a consultation for a beta-lactam oral reintroduction test.
排除标准
- •Refusal of the legal representatives of the subject for their child to participate in the study,
- •If his age permits, refusal of the subject to participate in the study,
- •Subject aged over 16,
- •Pregnancy,
- •Absence of affiliation of the subject to a social security scheme,
- •Skin tests with incriminated beta-lactam already made before the consultation,
- •Existence of contraindications to the realization of oral reintroduction drug test with the suspected antibiotic,
- •Existence of criteria in the initial reaction suggestive of a non-low risk of IgE-mediated or delayed hypersensitivity to the incriminated beta-lactam, Taking antihistamine, corticosteroids or beta-blockers within 5 days prior to the oral reintroduction drug test,
- •Travel abroad of the child scheduled within 7 days of the oral reintroduction drug test.
结局指标
主要结局
low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction
时间窗: At the end of the study, after 2 years.
Demonstrate a low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction, without previous skin tests, in children selected by a questionnaire as being at low risk of IgE-mediated or delayed
次要结局
- Risk evaluation(At the end of the study, after 2 years.)
- explain the occurrence of a reaction of IgE-mediated or delayed hypersensitivity(At the end of the study, after 2 years.)