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TerminatedNCT07194824Des-Al-PenUpdated Jan 13, 2026

A Penicillin Allergy Delabeling Inhospital Model Hospitalized Patients

An interventional study of Pragmatic allergy management according to risk stratification in Allergy Drug and Allergy Penicillin, sponsored by Althaia Xarxa Assistencial Universitària de Manresa. Terminated at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Althaia Xarxa Assistencial Universitària de Manresa · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to clear evidence of the intervention's effectiveness on a pre-planned interim analysis

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Apr 2024, registered Sep 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

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Conditions studied

  • Allergy Drug
  • Allergy Penicillin

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Keywords

  • De-labelling
  • Allergy manegement
  • beta-lactans allergy
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In context

Drug Hypersensitivity

66 studies on the registry are indexed under Drug Hypersensitivity; 20 are open to participants now.

This study's enrollment of 165 is above the median of 135 across 37 interventional studies indexed under Drug Hypersensitivity.

Browse Drug Hypersensitivity studies →

Lead sponsor

Althaia Xarxa Assistencial Universitària de Manresa is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria

- None

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
165 participants (actual)

Study arms

  • Experimental
    Patients with an active allergy label for beta-lactams admitted to hospital

    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,

    Other: Pragmatic allergy management according to risk stratification

Interventions

  • OtherPragmatic allergy management according to risk stratification

    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.

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What researchers measure

Primary outcomes

  1. Proportion of patients hospitalized in which the penicillin allergy label is removed

    Proportion of patients hospitalized in which the penicillin allergy label is removed

    Time frame: At enrollment time

07

Study locations

2 sites
  • Althaia
    Manresa, Barcelona 08243, Spain
  • C/ dr.Joan Soler 1-3
    Manresa, Barcelona 08243, Spain
08

References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07194824
Lead sponsor
Althaia Xarxa Assistencial Universitària de Manresa
Responsible party
Sponsor
First posted
Sep 26, 2025
Start date
Apr 4, 2024
Primary completion
May 23, 2025
Completion
May 25, 2025
Last update
Jan 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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