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Clinical Trials in France / NCT07002814
Recruiting Observational

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

NCT07002814 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-06
Last updated
2026-05-06

Condition(s) studied

Allergy

Study 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

Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpital Necker - Enfants Malades Paris France Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07002814 on ClinicalTrials.gov ↗ ← All trials in France