Direct oral antibiotic challenge to remove beta-lactam allergy label in children in private clinics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Many children are labeled allergic to beta-lactam antibiotics even though only a small fraction have true allergy, and most reported reactions are delayed and benign. Current guidelines support direct oral challenge (DOC) for these delayed reactions, but most data come from hospital-based settings. This observational study documents DOCs performed in private medical practices for children aged 0–17 with suspected mild delayed reactions and includes a follow-up visit 7–14 days after the challenge. The goal is to determine the feasibility and safety of delivering DOCs in primary care settings to inform practical recommendations.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hôpital Necker - Enfants Malades
  Paris, France Recruiting

Study contacts

• Principal investigator: Sebastien LE, MD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Sebastien LE, MD
• Email: sebastien.le@aphp.fr
• Phone: 06 35 14 12 41

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.