RecruitingNCT07002814

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

200 participants

Start Date

Jun 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Max Age: 17 Years

Inclusion Criteria5

  • 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 Criteria1

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

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Locations(1)

Hôpital Necker - Enfants Malades

Paris, France

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NCT07002814


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