Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 26, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a way to safely test children who might have a mild allergy to certain antibiotics called beta-lactams, which include medications like amoxicillin. The goal is to see if it's possible to conduct a simple test, known as a direct oral challenge, in a regular doctor's office. This test will help determine if children really have an allergy or if they can safely take these medications without any problems. If successful, the findings could help doctors develop guidelines for testing in primary care settings.

To be eligible for this trial, children aged 0 to 17 who have had a mild allergic reaction to antibiotics and meet specific criteria can participate. This includes those with delayed reactions that occur more than an hour after taking the medication, such as a rash or hives, but without severe symptoms. Participants will undergo the oral challenge test and will have a follow-up visit within two weeks to check on their progress. It's important to note that if a child or their parent does not want their information used in the study, they will not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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).
• Exclusion Criteria:
• • Informed children or holders of parental authority objecting to the use of patient data in the study.