Direct oral antibiotic challenge to remove beta-lactam allergy label in children in private clinics
Feasibility of Direct Oral Challenges in Private Practice Setting for the Evaluation of Mild Delayed Reactions to Beta-lactams in Children
This study will try giving a supervised small dose of a beta-lactam antibiotic in private pediatric clinics to see if children labeled as allergic actually tolerate it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT07002814 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 0–17 with a suspected mild delayed reaction (>1 hour after starting) to amoxicillin (± clavulanate), cefpodoxime, or cefixime who underwent a DOC in private practice and can attend a 7–14 day follow-up are ideal candidates.
Not a fit: Children with signs of severe cutaneous adverse reactions (bullae, mucosal involvement, target lesions, facial edema, organ impairment), prolonged reactions >7 days, immediate severe reactions, or whose guardians refuse use of data are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could help safely remove incorrect beta-lactam allergy labels from children so they can receive first-line antibiotics, lowering use of broader agents and related harms.
How similar studies have performed: Previous work includes over 8,300 pediatric DOCs, mostly hospital-based, showing a favorable safety profile and low confirmed allergy rates, but data specifically from private practice pediatric settings are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.