About this trial
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
This trial does not accept healthy volunteersQualifiers
Population: Children's age between 0 and 17 years
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).
Disqualifiers
Informed children or holders of parental authority objecting to the use of patient data in the study.
Trial population
Child who underwent a direct oral challenge in a private practice setting for suspected mild delayed allergy to a beta-lactam
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Feasibility of direct oral challenge (DOC) for beta-lactam allergy assessment
Demonstrate the feasibility of direct oral challenges (DOCs) performed in private medical practices for the evaluation of delayed and benign reactions to beta-lactams in children by collecting the amount of positive and negative DOC results and benign reactions description.
Secondary outcomes
Negative and positive tests reaction nature comparison
Collect and compare the nature of reactions between children with positive and negative direct oral challenge
Negative and positive tests reaction chronology comparison
Collect and compare chronology of reactions between children with positive and negative direct oral challenge.
Negative and positive tests reaction duration comparison
Collect and compare duration of reactions between children with positive and negative direct oral challenge.
Negative and positive tests reactions index comparison
Index reactions between children with positive and negative direct oral challenge.
Sponsors and contacts
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator