An observational study in Allergy, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 200 is above the median of 166 across 327 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Child who underwent a direct oral challenge in a private practice setting for suspected mild delayed allergy to a beta-lactam
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Exclusion Criteria:
Children previously labeled with suspected beta-lactam allergy, requiring a direct oral challenge (DOC) to confirm or rule out true hypersensitivity
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.
Time frame: Day 14
Negative and positive tests reaction nature comparison
Collect and compare the nature of reactions between children with positive and negative direct oral challenge
Time frame: Day 14
Negative and positive tests reaction chronology comparison
Collect and compare chronology of reactions between children with positive and negative direct oral challenge.
Time frame: Day 14
Negative and positive tests reaction duration comparison
Collect and compare duration of reactions between children with positive and negative direct oral challenge.
Time frame: Day 14
Negative and positive tests reactions index comparison
Index reactions between children with positive and negative direct oral challenge.
Time frame: Day 14
Reactions nature in positive tests
Collect and analyse the nature of reactions in positive direct oral challenge
Time frame: Day 14
Reactions extension in positive tests
Collect and analyse the extension of reactions in positive direct oral challenge
Time frame: Day 14
Reactions duration in positive tests
Collect and analyse the duration of reactions in positive direct oral challenge
Time frame: Day 14
Plan to share: No
Start is estimated for Jun 2026; primary completion for Jun 2026, 0 months later.
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