NCT07002814 Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy
| NCT ID | NCT07002814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Allergy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-06 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-06 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Sebastien LE, MD
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT07002814 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07002814 currently recruiting?
Yes, NCT07002814 is actively recruiting participants. Contact the research team at sebastien.le@aphp.fr for enrollment information.
Where is the NCT07002814 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07002814 clinical trial?
NCT07002814 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Sebastien LE, MD at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 200 participants.