Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy

NCT07002814 | Recruiting

• 2 other identifiers: APHP250276ID-RBC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy

Keywords

Beta-lactams; Allerg; Allergology; Direct oral challenge

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 14

Secondary Outcomes (7)

• Negative and positive tests reaction nature comparison

  Day 14

• Negative and positive tests reaction chronology comparison

  Day 14

• Negative and positive tests reaction duration comparison

  Day 14

• Negative and positive tests reactions index comparison

  Day 14

• Reactions nature in positive tests

  Day 14

Study Arms (1)

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

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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).

You may not qualify if:

• Informed children or holders of parental authority objecting to the use of patient data in the study.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker - Enfants Malades

Paris, 75015, France

RECRUITING

Related Publications (11)

• 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.

  PMID: 31826341 BACKGROUND

• 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.

  PMID: 36122788 BACKGROUND

• 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.

  PMID: 26416157 BACKGROUND

• 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.

  PMID: 32446963 BACKGROUND

• 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.

  PMID: 36528293 BACKGROUND

• 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.

  PMID: 24697291 BACKGROUND

• 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.

  PMID: 36738783 BACKGROUND

• 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.

  PMID: 36128691 BACKGROUND

• 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.

  PMID: 37572750 BACKGROUND

• 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. Erratum In: Lancet. 2017 Oct 28;390(10106):1948. doi: 10.1016/S0140-6736(17)31656-2.

  PMID: 28476287 BACKGROUND

• 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.

  PMID: 31087349 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Sebastien LE, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastien LE, MD

CONTACT

06 35 14 12 41; sebastien.le@aphp.fr

Gael Plastow

CONTACT

01 44 38 18 57; gael.plastow@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: June 4, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)