AllergyBetalactavilleNCT07002814
Direct Oral Challenges in Private Practice Setting to Delabeling Children With Beta-lactam Allergy
An observational study of Allergy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Allergy
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Child who underwent a direct oral challenge in a private practice setting for suspected mild delayed allergy to a beta-lactam
Who may be able to join
- 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).
Who cannot join
- Informed children or holders of parental authority objecting to the use of patient data in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker - Enfants Malades
Paris, 75015
About this study
Official title: Feasibility of Direct Oral Challenges in Private Practice Setting for the Evaluation of Mild Delayed Reactions to Beta-lactams in Children
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.
Read the 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
- Conditions
- Allergy
- Keywords
- Beta-lactams, Allerg, Allergology, Direct oral challenge
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14
Secondary outcomes (7)
Negative and positive tests reaction nature comparison
Collect and compare the nature of reactions between children with positive and negative direct oral challenge
Measured: Day 14
Negative and positive tests reaction chronology comparison
Collect and compare chronology of reactions between children with positive and negative direct oral challenge.
Measured: Day 14
Negative and positive tests reaction duration comparison
Collect and compare duration of reactions between children with positive and negative direct oral challenge.
Measured: Day 14
Negative and positive tests reactions index comparison
Index reactions between children with positive and negative direct oral challenge.
Measured: Day 14
Reactions nature in positive tests
Collect and analyse the nature of reactions in positive direct oral challenge
Measured: Day 14
Reactions extension in positive tests
Collect and analyse the extension of reactions in positive direct oral challenge
Measured: Day 14
Reactions duration in positive tests
Collect and analyse the duration of reactions in positive direct oral challenge
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study startJun 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sebastien LE, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002814
- Sponsor's protocol ID
- APHP250276
- Other IDs
- ID-RBC
- Acronym
- Betalactaville
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31826341Khan 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.
PubMed 36122788Gomes 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.
PubMed 26416157Sousa-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.
PubMed 32446963Srisuwatchari 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.
PubMed 36528293Demoly 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.
PubMed 24697291Chow 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.
PubMed 36738783Savic 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.
PubMed 36128691Waldron 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.
PubMed 37572750Duong 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.
PubMed 28476287Jaoui 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.
PubMed 31087349
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Direct Oral Challenges in Private Practice Setting for the Evaluation of Mild Delayed Reactions to Beta-lactams in Children
- ClinicalTrials.gov ID
- NCT07002814
- Acronym / sponsor ID
- Betalactaville / APHP250276
- Conditions
- Allergy
- Keywords
- Beta-lactams, Allerg, Allergology, Direct oral challenge
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child who underwent a direct oral challenge in a private practice setting for suspected mild delayed allergy to a beta-lactam
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Informed children or holders of parental authority objecting to the use of patient data in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of direct oral challenge (DOC) for beta-lactam allergy assessment
Time frame: 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.
7 secondary outcomes
Negative and positive tests reaction nature comparison
Time frame: Day 14
Negative and positive tests reaction chronology comparison
Time frame: Day 14
Negative and positive tests reaction duration comparison
Time frame: Day 14
Negative and positive tests reactions index comparison
Time frame: Day 14
Reactions nature in positive tests
Time frame: Day 14
Reactions extension in positive tests
Time frame: Day 14
Reactions duration in positive tests
Time frame: Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 31826341Castells 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.
- Background: PubMed 36122788Khan 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.
- Background: PubMed 26416157Gomes 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.
- Background: PubMed 32446963Sousa-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.
- Background: PubMed 36528293Srisuwatchari 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.
- Background: PubMed 24697291Demoly 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.
- Background: PubMed 36738783Chow 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.
- Background: PubMed 36128691Savic 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.
- Background: PubMed 37572750Waldron 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.
- Background: PubMed 28476287Duong 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.
- Background: PubMed 31087349Jaoui 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastien LE, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastien LE, MD (06 35 14 12 41 ext. +33, sebastien.le@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of direct oral challenge (DOC) for beta-lactam allergy assessment (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07002814, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.