Allergy
Conditions
Keywords
Beta-lactams, Allerg, Allergology, Direct oral challenge
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
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of direct oral challenge (DOC) for beta-lactam allergy assessment | Day 14 | 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
| Measure | Time frame | Description |
|---|---|---|
| Negative and positive tests reaction nature comparison | Day 14 | Collect and compare the nature of reactions between children with positive and negative direct oral challenge |
| Negative and positive tests reaction chronology comparison | Day 14 | Collect and compare chronology of reactions between children with positive and negative direct oral challenge. |
| Negative and positive tests reaction duration comparison | Day 14 | Collect and compare duration of reactions between children with positive and negative direct oral challenge. |
| Negative and positive tests reactions index comparison | Day 14 | Index reactions between children with positive and negative direct oral challenge. |
| Reactions nature in positive tests | Day 14 | Collect and analyse the nature of reactions in positive direct oral challenge |
| Reactions extension in positive tests | Day 14 | Collect and analyse the extension of reactions in positive direct oral challenge |
| Reactions duration in positive tests | Day 14 | Collect and analyse the duration of reactions in positive direct oral challenge |
Countries
France
Contacts
CONTACTSebastien LE, MD
CONTACTGael Plastow
PRINCIPAL_INVESTIGATORSebastien LE, MD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed