A Penicillin Allergy Delabeling Inhospital Model Hospitalized Patients

NCT07194824 | Terminated

• 1 other identifier: 23/028
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Allergy Drug; Allergy Penicillin

Keywords

De-labelling; Allergy manegement; beta-lactans allergy

Outcome Measures

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

  At enrollment time

Study Arms (1)

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,

Other: Pragmatic allergy management according to risk stratification

Interventions

Pragmatic allergy management according to risk stratification OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- None

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead

Study Sites (2)

Althaia

Manresa, Barcelona, 08243, Spain

Location

C/ dr.Joan Soler 1-3

Manresa, Barcelona, 08243, Spain

Location

Related Publications (13)

• 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.

  PMID: 28283158 BACKGROUND

• 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.

  PMID: 10927711 BACKGROUND

• 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.

  PMID: 24188976 BACKGROUND

• 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.

  PMID: 38758551 BACKGROUND

• 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

• 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.

  PMID: 24801461 BACKGROUND

• 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.

  PMID: 31749148 BACKGROUND

• 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.

  PMID: 28742226 BACKGROUND

• 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.

  PMID: 31362351 BACKGROUND

• 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.

  PMID: 38084822 BACKGROUND

• 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.

  PMID: 31049971 BACKGROUND

• 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.

  PMID: 36707291 BACKGROUND

• 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.

  PMID: 30558872 BACKGROUND

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical evaluation study of a new care process, prospective, open, carried out in a single centre, ALTHAIA University Assistance Network of Manresa.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: April 4, 2024
• Primary Completion: May 23, 2025
• Study Completion: May 25, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)