Actively Recruiting

Age: 0 - 17Years
All Genders
NCT07002814

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-05-06

200

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

U

URC-CIC Paris Descartes Necker Cochin

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child between 0 and 17 years old
  • Child has undergone a direct oral challenge in private practice for suspected delayed allergy to amoxicillin +/- clavulanate, cefpodoxime, or cefixime
  • Reaction occurred more than 1 hour after starting treatment
  • Reaction is mild, such as isolated urticaria or maculopapular rash
  • No signs of severe skin reactions like erythroderma, bullae, vesicles, pustules, target lesions, or mucosal involvement
  • Child has no facial swelling, general condition impairment, organ failure, or reaction lasting more than 7 days
  • Follow-up consultation occurred within 7 to 14 days after challenge
Not Eligible

You will not qualify if you...

  • Child or parent/legal guardian objects to use of patient data in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hôpital Necker - Enfants Malades

Paris, France, 75015

Actively Recruiting

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Research Team

S

Sebastien LE, MD

CONTACT

G

Gael Plastow

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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