跳至主要内容
临床试验/NCT07002814
NCT07002814招募中不适用

Feasibility of Direct Oral Challenges in Private Practice Setting for the Evaluation of Mild Delayed Reactions to Beta-lactams in Children

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Feasibility of direct oral challenge (DOC) for beta-lactam allergy assessment

研究概览

简要总结

The purpose of this study is to demonstrate the feasibility of direct oral challenge performed in private practice setting for children with suspected benign delayed allergy to beta-lactams.

The results of this study could help establish recommendations for conducting direct oral challenge in primary care settings to delabeling children with benign delayed reactions to beta-lactams.

详细描述

Approximately 10% of children are labeled as allergic to beta-lactams (BL). Consequently, they receive alternative antibiotics with a broader spectrum but lower efficacy, leading to increased infectious morbidity and mortality, a higher risk of colonization with antibiotic-resistant bacteria, and elevated healthcare costs. However, true BL allergy is only confirmed in 5-10% of cases. Therefore, an essential challenge is to promptly identify non-allergic children to prevent unnecessary medical restrictions.

The most common reactions are delayed and benign. Current guidelines recommend evaluating these reactions through direct oral challenge (DOC) without prior allergological assessment, as traditional diagnostic methods, particularly skin tests, have poor sensitivity in this context. However, the optimal setting for conducting these tests remains debated, particularly regarding whether they can be initiated in hospital settings or private medical practices.

To date, over 8,300 DOCs have been performed in children, predominantly in hospital-based consultations. These tests have demonstrated a favorable safety profile, with positive DOC reactions often being of the same nature and less severe than the initial reported reaction. While many physicians perform DOCs in private practice, data on their use in pediatric populations remain scarce.

The primary objective of this study is to assess the feasibility of DOCs conducted in private medical practices for children with suspected benign delayed allergy to BL

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Population: Children's age between 0 and 17 years
  • •Child who has undergone a direct oral challenge in a private medical practice and a follow-up consultation within 7 to 14 days for suspected delayed allergy to amoxicillin +/- clavulanate or cefpodoxime or cefixime with the following characteristics:
  • •delayed reaction (onset > 1 hour after treatment start),
  • •mild reaction (isolated urticaria or Maculopapular exanthema),
  • •Absence of warning signs suggestive of a severe cutaneous adverse reaction (erythroderma, presence of bullae, vesicles, pustules, target lesions, involvement of oral, genital, or ocular mucosa, facial edema, general condition impairment, organ failure, duration > 7 days).

排除标准

  • •Informed children or holders of parental authority objecting to the use of patient data in the study.

研究组 & 干预措施

Children requiring a direct oral challenge (DOC)

Children previously labeled with suspected beta-lactam allergy, requiring a direct oral challenge (DOC) to confirm or rule out true hypersensitivity

结局指标

主要结局

Feasibility of direct oral challenge (DOC) for beta-lactam allergy assessment

时间窗: Day 14

Demonstrate the feasibility of direct oral challenges (DOCs) performed in private medical practices for the evaluation of delayed and benign reactions to beta-lactams in children by collecting the amount of positive and negative DOC results and benign reactions description.

次要结局

  • Negative and positive tests reaction nature comparison(Day 14)
  • Negative and positive tests reaction chronology comparison(Day 14)
  • Negative and positive tests reaction duration comparison(Day 14)
  • Negative and positive tests reactions index comparison(Day 14)
  • Reactions nature in positive tests(Day 14)
  • Reactions extension in positive tests(Day 14)
  • Reactions duration in positive tests(Day 14)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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