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

Recruiting now

Conditions studied: Allergy

In brief

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.

Key facts

Study ID

NCT07002814

Run by

Assistance Publique - Hôpitaux de Paris

People needed

200

Starts

2026-06-01

Expected to finish

2027-06-01

Last updated by the study team

2026-05-06

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

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

Where it is running

• Hôpital Necker - Enfants Malades — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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