Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy
NCT ID: NCT07002814
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2025-06-30
2026-06-30
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Children requiring a direct oral challenge (DOC)
Children previously labeled with suspected beta-lactam allergy, requiring a direct oral challenge (DOC) to confirm or rule out true hypersensitivity
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
17 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Sebastien LE, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Necker - Enfants Malades
Paris, , France
Countries
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Central Contacts
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References
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Castells M, Khan DA, Phillips EJ. Penicillin Allergy. N Engl J Med. 2019 Dec 12;381(24):2338-2351. doi: 10.1056/NEJMra1807761. No abstract available.
Khan DA, Banerji A, Blumenthal KG, Phillips EJ, Solensky R, White AA, Bernstein JA, Chu DK, Ellis AK, Golden DBK, Greenhawt MJ, Horner CC, Ledford D, Lieberman JA, Oppenheimer J, Rank MA, Shaker MS, Stukus DR, Wallace D, Wang J; Chief Editor(s):; Khan DA, Golden DBK, Shaker M, Stukus DR; Workgroup Contributors:; Khan DA, Banerji A, Blumenthal KG, Phillips EJ, Solensky R, White AA; Joint Task Force on Practice Parameters Reviewers:; Bernstein JA, Chu DK, Ellis AK, Golden DBK, Greenhawt MJ, Horner CC, Ledford D, Lieberman JA, Oppenheimer J, Rank MA, Shaker MS, Stukus DR, Wallace D, Wang J. Drug allergy: A 2022 practice parameter update. J Allergy Clin Immunol. 2022 Dec;150(6):1333-1393. doi: 10.1016/j.jaci.2022.08.028. Epub 2022 Sep 17. No abstract available.
Gomes ER, Brockow K, Kuyucu S, Saretta F, Mori F, Blanca-Lopez N, Ott H, Atanaskovic-Markovic M, Kidon M, Caubet JC, Terreehorst I; ENDA/EAACI Drug Allergy Interest Group. Drug hypersensitivity in children: report from the pediatric task force of the EAACI Drug Allergy Interest Group. Allergy. 2016 Feb;71(2):149-61. doi: 10.1111/all.12774. Epub 2015 Nov 17.
Sousa-Pinto B, Tarrio I, Blumenthal KG, Araujo L, Azevedo LF, Delgado L, Fonseca JA. Accuracy of penicillin allergy diagnostic tests: A systematic review and meta-analysis. J Allergy Clin Immunol. 2021 Jan;147(1):296-308. doi: 10.1016/j.jaci.2020.04.058. Epub 2020 May 21.
Srisuwatchari W, Phinyo P, Chiriac AM, Saokaew S, Kulalert P. The Safety of the Direct Drug Provocation Test in Beta-Lactam Hypersensitivity in Children: A Systematic Review and Meta-Analysis. J Allergy Clin Immunol Pract. 2023 Feb;11(2):506-518. doi: 10.1016/j.jaip.2022.11.035. Epub 2022 Dec 14.
Demoly P, Adkinson NF, Brockow K, Castells M, Chiriac AM, Greenberger PA, Khan DA, Lang DM, Park HS, Pichler W, Sanchez-Borges M, Shiohara T, Thong BY. International Consensus on drug allergy. Allergy. 2014 Apr;69(4):420-37. doi: 10.1111/all.12350.
Chow TG, Patel G, Mohammed M, Johnson D, Khan DA. Delabeling penicillin allergy in a pediatric primary care clinic. Ann Allergy Asthma Immunol. 2023 May;130(5):667-669. doi: 10.1016/j.anai.2023.01.034. Epub 2023 Feb 2. No abstract available.
Savic L, Ardern-Jones M, Avery A, Cook T, Denman S, Farooque S, Garcez T, Gold R, Jay N, Krishna MT, Leech S, McKibben S, Nasser S, Premchand N, Sandoe J, Sneddon J, Warner A. BSACI guideline for the set-up of penicillin allergy de-labelling services by non-allergists working in a hospital setting. Clin Exp Allergy. 2022 Oct;52(10):1135-1141. doi: 10.1111/cea.14217. Epub 2022 Sep 21.
Waldron JL, Hackett J, Chaung YL, Rodway P, Clark M, Trubiano JA, Chua KYL. Oral penicillin challenge in adult community practice and primary care in Australia. J Allergy Clin Immunol Pract. 2023 Dec;11(12):3786-3788.e3. doi: 10.1016/j.jaip.2023.08.013. Epub 2023 Aug 10. No abstract available.
Duong TA, Valeyrie-Allanore L, Wolkenstein P, Chosidow O. Severe cutaneous adverse reactions to drugs. Lancet. 2017 Oct 28;390(10106):1996-2011. doi: 10.1016/S0140-6736(16)30378-6. Epub 2017 May 2.
Jaoui A, Delalande D, Siouti S, Benoist G, Seve E, Ponvert C, Scheinmann P, Faour H, Neuraz A, Garcelon N, Delacourt C, Lezmi G. Safety and cost effectiveness of supervised ambulatory drug provocation tests in children with mild non-immediate reactions to beta-lactams. Allergy. 2019 Dec;74(12):2482-2484. doi: 10.1111/all.13871. Epub 2019 May 31. No abstract available.
Other Identifiers
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ID-RBC
Identifier Type: OTHER
Identifier Source: secondary_id
APHP250276
Identifier Type: -
Identifier Source: org_study_id
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