Clinical trial NCT07002814: Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy
Official title: Feasibility of Direct Oral Challenges in Private Practice Setting for the Evaluation of Mild Delayed Reactions to Beta-lactams in Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Allergy
Keywords: Beta-lactams
Allerg
Allergology
Direct oral challenge
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 200
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child who underwent a direct oral challenge in a private practice setting for suspected mild delayed allergy to a beta-lactam

Brief summary: 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.

Detailed description: Approximately 10% of children are labeled as allergic to beta-lactams (BL). Consequently, they receive alternative antibiotics with a broader spectrum but lower efficacy, leading to increased infectious morbidity and mortality, a higher risk of colonization with antibiotic-resistant bacteria, and elevated healthcare costs. However, true BL allergy is only confirmed in 5-10% of cases. Therefore, an essential challenge is to promptly identify non-allergic children to prevent unnecessary medical restrictions.

The most common reactions are delayed and benign. Current guidelines recommend evaluating these reactions through direct oral challenge (DOC) without prior allergological assessment, as traditional diagnostic methods, particularly skin tests, have poor sensitivity in this context. However, the optimal setting for conducting these tests remains debated, particularly regarding whether they can be initiated in hospital settings or private medical practices.

To date, over 8,300 DOCs have been performed in children, predominantly in hospital-based consultations. These tests have demonstrated a favorable safety profile, with positive DOC reactions often being of the same nature and less severe than the initial reported reaction. While many physicians perform DOCs in private practice, data on their use in pediatric populations remain scarce.

The primary objective of this study is to assess the feasibility of DOCs conducted in private medical practices for children with suspected benign delayed allergy to BL

Eligibility 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.

Primary outcomes:
measure: Feasibility of direct oral challenge (DOC) for beta-lactam allergy assessment
timeFrame: Day 14
Secondary outcomes:
measure: Negative and positive tests reaction nature comparison
timeFrame: Day 14
measure: Negative and positive tests reaction chronology comparison
timeFrame: Day 14
measure: Negative and positive tests reaction duration comparison
timeFrame: Day 14
measure: Negative and positive tests reactions index comparison
timeFrame: Day 14
measure: Reactions nature in positive tests
timeFrame: Day 14
measure: Reactions extension in positive tests
timeFrame: Day 14
measure: Reactions duration in positive tests
timeFrame: Day 14
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker - Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sebastien LE, MD
role: PRINCIPAL_INVESTIGATOR
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