Status:
NOT_YET_RECRUITING
Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Allergy
Eligibility:
All Genders
Up to 17 years
Brief 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 resu...
Detailed Description
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 infectio...
Eligibility Criteria
Inclusion
- 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
- Informed children or holders of parental authority objecting to the use of patient data in the study.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07002814
Start Date
June 1 2025
End Date
June 1 2026
Last Update
June 4 2025
Active Locations (1)
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1
Hôpital Necker - Enfants Malades
Paris, France, 75015