Allergy DrugDes-Al-PenNCT07194824

A Penicillin Allergy Delabeling Inhospital Model Hospitalized Patients

A study testing Pragmatic allergy management according to risk stratification in people with Allergy Drug and Allergy Penicillin, run by Althaia Xarxa Assistencial Universitària de Manresa at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Design, implementation and analysis of an allergy assessment and management model beta-lactams in hospitalized patients Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Allergy Drug, Allergy Penicillin
What is being tested?: Pragmatic allergy management according to risk stratification
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 165 participants
Where: 2 sitesSpain
Study dates: 4 Apr 2024to 25 May 2025
Phase: Interventional
Are there results?: None posted in the registry

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age > 18 years
Ability to understand the study after reading the patient information sheet (Appendix II) and providing signed consent for participation (Appendix III: informed consent form).
Patients with a reported allergy to penicillin and/or cephalosporins that has not been investigated or with inconclusive prior testing.

Who cannot join

None

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Althaia
Manresa, Barcelona, 08243
C/ dr.Joan Soler 1-3
Manresa, Barcelona, 08243

Other trials in Spain

About this study

Official title: Design, Implementation and Analysis of a Penicillin Allergy Delabeling Model in Hospitalized Patients

Design, implementation and analysis of an allergy assessment and management model beta-lactams in hospitalized patients

Read the detailed description

To evaluate the impact of a healthcare process for risk stratification based on the clinical history and the application of a structured questionnaire, on the Proportion of hospitalized patients in whom the penicillin allergy label is removed

Conditions: Allergy Drug, Allergy Penicillin
Being tested: Pragmatic allergy management according to risk stratification
Keywords: De-labelling, Allergy manegement, beta-lactans allergy
Medical subject headings: Drug Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pragmatic allergy management according to risk stratificationOther
Intervention based on allergy risk stratification. Tipus A) Patients in this group can undergo direct delabeling without the need for exposure, with this being documented in the EMR. If the patient refuses, an exposure to penicillin and/or cephalosporin will be performed. Once completed, de-labeling can proceed without the need for re-exposure.
Tipus B) Indication for use of a penicillin: Oral exposure to 250 mg of amoxicillin.
- Indication for cephalosporin : administration of a cephalosporin that exhibits the lowest level of cross-reactivity with penicillin.
Re-exposure to penicillin/ cephalosporin or both is performed at least 2 weeks after the first tolerated exposure. De-labeling is performed when tolerance to re-exposure is verified.
Tipus C) These high-risk patients are managed following the protocol for the treatment of patients with beta-lactam allergy, referring them to allergy consultation for further specific test.

Study groups in NCT07194824
Study group	Role	What they receive
Patients with an active allergy label for beta-lactams admitted to hospital	Experimental	Clinical evaluation involving a review of the patient's history and a structured questionnaire, allows stratification of allergy risk into 3 categories, and managed accordingly. 1) Tipus A) Patients with a non-immune-mediated adverse reaction or with posterior tolerance. 2) Grup B) Patients with low risk potentiallly immune-mediated mechanism are considered candidates for exposure and re-exposure to penicillin and/or cephalosporins, as clinically indicted. 3) Grup C) Patients with a previous adverse reaction considered high-risk Type C, IgE-mediated or non-immediate Type II-IV reactions, Receives: Other: Pragmatic allergy management according to risk stratification

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of patients hospitalized in which the penicillin allergy label is removed
Proportion of patients hospitalized in which the penicillin allergy label is removed
Measured: At enrollment time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 202425 May 2025

First posted26 Sep 2025
Study start4 Apr 2024
Primary completion23 May 2025
Study completion25 May 2025

Why it stopped: Due to clear evidence of the intervention's effectiveness on a pre-planned interim analysis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Allergy DrugStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Clinical evaluation study of a new care process, prospective, open, carried out in a single centre, ALTHAIA University Assistance Network of Manresa.
Masking: None (open label)
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07194824
Sponsor's protocol ID: 23/028
Acronym: Des-Al-Pen
Status last verified: Jan 2026
First submitted: 19 Sep 2025
Last updated: 13 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Penicillin Allergy in Antibiotic Resistance Workgroup. Penicillin Allergy Testing Should Be Performed Routinely in Patients with Self-Reported Penicillin Allergy. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):333-334. doi: 10.1016/j.jaip.2016.12.010. No abstract available.
PubMed 28283158
MacLaughlin EJ, Saseen JJ, Malone DC. Costs of beta-lactam allergies: selection and costs of antibiotics for patients with a reported beta-lactam allergy. Arch Fam Med. 2000 Aug;9(8):722-6. doi: 10.1001/archfami.9.8.722.
PubMed 10927711
Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin "allergy" in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014 Mar;133(3):790-6. doi: 10.1016/j.jaci.2013.09.021. Epub 2013 Nov 1.
PubMed 24188976
Gray MP, Kellum JA, Kirisci L, Boyce RD, Kane-Gill SL. Long-Term Outcomes Associated With beta-Lactam Allergies. JAMA Netw Open. 2024 May 1;7(5):e2412313. doi: 10.1001/jamanetworkopen.2024.12313.
PubMed 38758551
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 31826341
Blumenthal KG, Saff RR, Banerji A. Evaluation and management of a patient with multiple drug allergies. Allergy Asthma Proc. 2014 May-Jun;35(3):197-203. doi: 10.2500/aap.2014.35.3739.
PubMed 24801461
Romano A, Atanaskovic-Markovic M, Barbaud A, Bircher AJ, Brockow K, Caubet JC, Celik G, Cernadas J, Chiriac AM, Demoly P, Garvey LH, Mayorga C, Nakonechna A, Whitaker P, Torres MJ. Towards a more precise diagnosis of hypersensitivity to beta-lactams - an EAACI position paper. Allergy. 2020 Jun;75(6):1300-1315. doi: 10.1111/all.14122.
PubMed 31749148
Inglis JM, Caughey GE, Smith W, Shakib S. Documentation of penicillin adverse drug reactions in electronic health records: inconsistent use of allergy and intolerance labels. Intern Med J. 2017 Nov;47(11):1292-1297. doi: 10.1111/imj.13558.
PubMed 28742226
Chaudhry SB, Veve MP, Wagner JL. Cephalosporins: A Focus on Side Chains and beta-Lactam Cross-Reactivity. Pharmacy (Basel). 2019 Jul 29;7(3):103. doi: 10.3390/pharmacy7030103.
PubMed 31362351
Dona I, Torres MJ, Celik G, Phillips E, Tanno LK, Castells M. Changing patterns in the epidemiology of drug allergy. Allergy. 2024 Mar;79(3):613-628. doi: 10.1111/all.15970. Epub 2023 Dec 12.
PubMed 38084822
Stone CA Jr, Trubiano J, Coleman DT, Rukasin CRF, Phillips EJ. The challenge of de-labeling penicillin allergy. Allergy. 2020 Feb;75(2):273-288. doi: 10.1111/all.13848. Epub 2019 May 26.
PubMed 31049971
Pano-Pardo JR, Rodilla EM, Sacristan SC, Saldana JLC, Parraga LP, Leon JLDP, Genti PR, Oviedo AR, Jaen MJT, Vidal-Cortes P, Sanz CC. Management of patients with suspected or confirmed antibiotic allergy. Executive summary of guidance from the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), the Spanish Society of Allergy and Clinical Immunology (SEAIC), the Spanish Society of Hospital Pharmacy (SEFH) and the Spanish Society of Intensive Medicine and Coronary Care Units (SEMICYUC). Enferm Infecc Microbiol Clin (Engl Ed). 2023 Mar;41(3):181-186. doi: 10.1016/j.eimce.2022.08.010. Epub 2023 Jan 25.
PubMed 36707291
Blumenthal KG, Peter JG, Trubiano JA, Phillips EJ. Antibiotic allergy. Lancet. 2019 Jan 12;393(10167):183-198. doi: 10.1016/S0140-6736(18)32218-9. Epub 2018 Dec 14.
PubMed 30558872

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Design, Implementation and Analysis of a Penicillin Allergy Delabeling Model in Hospitalized Patients
ClinicalTrials.gov ID: NCT07194824
Acronym / sponsor ID: Des-Al-Pen / 23/028
Conditions: Allergy Drug, Allergy Penicillin
Keywords: De-labelling, Allergy manegement, beta-lactans allergy
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to clear evidence of the intervention's effectiveness on a pre-planned interim analysis
Enrolment: 165 participants (actual)
Lead sponsor: Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
Study start: 4 Apr 2024 (actual)
Primary completion: 23 May 2025 (actual)
Study completion: 25 May 2025 (actual)
First posted: 26 Sep 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.

Design, implementation and analysis of an allergy assessment and management model beta-lactams in hospitalized patients

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Clinical evaluation study of a new care process, prospective, open, carried out in a single centre, ALTHAIA University Assistance Network of Manresa.

Arm	Type	Receives
Patients with an active allergy label for beta-lactams admitted to hospital	Experimental	Other: Pragmatic allergy management according to risk stratificationClinical evaluation involving a review of the patient's history and a structured questionnaire, allows stratification of allergy risk into 3 categories, and managed accordingly. 1) Tipus A) Patients with a non-immune-mediated adverse reaction or with posterior tolerance. 2) Grup B) Patients with low risk potentiallly immune-mediated mechanism are considered candidates for exposure and re-exposure to penicillin and/or cephalosporins, as clinically indicted. 3) Grup C) Patients with a previous adverse reaction considered high-risk Type C, IgE-mediated or non-immediate Type II-IV reactions,

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age > 18 years
Ability to understand the study after reading the patient information sheet (Appendix II) and providing signed consent for participation (Appendix III: informed consent form).
Patients with a reported allergy to penicillin and/or cephalosporins that has not been investigated or with inconclusive prior testing.

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pragmatic allergy management according to risk stratificationIntervention based on allergy risk stratification. Tipus A) Patients in this group can undergo direct delabeling without the need for exposure, with this being documented in the EMR. If the patient refuses, an exposure to penicillin and/or cephalosporin will be performed. Once completed, de-labeling can proceed without the need for re-exposure. Tipus B) Indication for use of a penicillin: Oral exposure to 250 mg of amoxicillin. - Indication for cephalosporin : administration of a cephalosporin that exhibits the lowest level of cross-reactivity with penicillin. Re-exposure to penicillin/ cephalosporin or both is performed at least 2 weeks after the first tolerated exposure. De-labeling is performed when tolerance to re-exposure is verified. Tipus C) These high-risk patients are managed following the protocol for the treatment of patients with beta-lactam allergy, referring them to allergy consultation for further specific test.	Other	Patients with an active allergy label for beta-lactams admitted to hospital

Primary outcome

Proportion of patients hospitalized in which the penicillin allergy label is removed
Time frame: At enrollment time
Proportion of patients hospitalized in which the penicillin allergy label is removed

Results and safety

The study was stopped early (reason given: Due to clear evidence of the intervention's effectiveness on a pre-planned interim analysis). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
Background: PubMed 28283158Penicillin Allergy in Antibiotic Resistance Workgroup. Penicillin Allergy Testing Should Be Performed Routinely in Patients with Self-Reported Penicillin Allergy. J Allergy Clin Immunol Pract. 2017 Mar-Apr;5(2):333-334. doi: 10.1016/j.jaip.2016.12.010. No abstract available.
Background: PubMed 10927711MacLaughlin EJ, Saseen JJ, Malone DC. Costs of beta-lactam allergies: selection and costs of antibiotics for patients with a reported beta-lactam allergy. Arch Fam Med. 2000 Aug;9(8):722-6. doi: 10.1001/archfami.9.8.722.
Background: PubMed 24188976Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin "allergy" in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014 Mar;133(3):790-6. doi: 10.1016/j.jaci.2013.09.021. Epub 2013 Nov 1.
Background: PubMed 38758551Gray MP, Kellum JA, Kirisci L, Boyce RD, Kane-Gill SL. Long-Term Outcomes Associated With beta-Lactam Allergies. JAMA Netw Open. 2024 May 1;7(5):e2412313. doi: 10.1001/jamanetworkopen.2024.12313.
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 24801461Blumenthal KG, Saff RR, Banerji A. Evaluation and management of a patient with multiple drug allergies. Allergy Asthma Proc. 2014 May-Jun;35(3):197-203. doi: 10.2500/aap.2014.35.3739.
Background: PubMed 31749148Romano A, Atanaskovic-Markovic M, Barbaud A, Bircher AJ, Brockow K, Caubet JC, Celik G, Cernadas J, Chiriac AM, Demoly P, Garvey LH, Mayorga C, Nakonechna A, Whitaker P, Torres MJ. Towards a more precise diagnosis of hypersensitivity to beta-lactams - an EAACI position paper. Allergy. 2020 Jun;75(6):1300-1315. doi: 10.1111/all.14122.
Background: PubMed 28742226Inglis JM, Caughey GE, Smith W, Shakib S. Documentation of penicillin adverse drug reactions in electronic health records: inconsistent use of allergy and intolerance labels. Intern Med J. 2017 Nov;47(11):1292-1297. doi: 10.1111/imj.13558.
Background: PubMed 31362351Chaudhry SB, Veve MP, Wagner JL. Cephalosporins: A Focus on Side Chains and beta-Lactam Cross-Reactivity. Pharmacy (Basel). 2019 Jul 29;7(3):103. doi: 10.3390/pharmacy7030103.
Background: PubMed 38084822Dona I, Torres MJ, Celik G, Phillips E, Tanno LK, Castells M. Changing patterns in the epidemiology of drug allergy. Allergy. 2024 Mar;79(3):613-628. doi: 10.1111/all.15970. Epub 2023 Dec 12.
Background: PubMed 31049971Stone CA Jr, Trubiano J, Coleman DT, Rukasin CRF, Phillips EJ. The challenge of de-labeling penicillin allergy. Allergy. 2020 Feb;75(2):273-288. doi: 10.1111/all.13848. Epub 2019 May 26.
Background: PubMed 36707291Pano-Pardo JR, Rodilla EM, Sacristan SC, Saldana JLC, Parraga LP, Leon JLDP, Genti PR, Oviedo AR, Jaen MJT, Vidal-Cortes P, Sanz CC. Management of patients with suspected or confirmed antibiotic allergy. Executive summary of guidance from the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), the Spanish Society of Allergy and Clinical Immunology (SEAIC), the Spanish Society of Hospital Pharmacy (SEFH) and the Spanish Society of Intensive Medicine and Coronary Care Units (SEMICYUC). Enferm Infecc Microbiol Clin (Engl Ed). 2023 Mar;41(3):181-186. doi: 10.1016/j.eimce.2022.08.010. Epub 2023 Jan 25.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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: stopped early, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

The study was stopped early (reason given: Due to clear evidence of the intervention's effectiveness on a pre-planned interim analysis). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients hospitalized in which the penicillin allergy label is removed (time frame: At enrollment time). 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 NCT07194824, which also lists 13 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 13 Jan 2026.