A Digital Stewardship Strategy for Patients With Reported Penicillin Allergy

NCT07604597 | Completed

• 1 other identifier: 25/066
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to evaluate whether a digital decision support tool integrated into the electronic medical record improves antibiotic prescribing in hospitalized patients with a reported allergy to penicillin. Around 5 out of 100 hospitalized patients at our center have a penicillin allergy label in their medical record. However, this allergy is confirmed in less than 10 out of 100 cases. Despite this, more than 90 out of 100 of these patients receive alternative antibiotics that may be less effective or less aligned with clinical guidelines. This study includes adults older than 16 years treated at Hospital Sant Joan de Déu de Manresa (Althaia) for infections that require systemic antibiotic treatment. Participants are those with a recorded penicillin allergy in their medical record or who report an allergy during their current hospital admission. The main questions this study aims to answer are: Does the use of a digital decision support tool increase the use of beta-lactam antibiotics (such as penicillins and cephalosporins) in patients with a reported penicillin allergy? Does the tool reduce the use of alternative antibiotic treatments that are less aligned with hospital guidelines? Participants will receive standard clinical care. In addition, healthcare professionals will use a digital tool integrated into the electronic medical record. This tool supports clinical decision-making by assessing individual allergy risk and aligning antibiotic selection with hospital treatment guidelines. The study will last approximately 15 months and will be conducted at a single hospital center.

Conditions

Penicillin Allergy; In-hospital Process Optimization

Keywords

penicillin allergy; beta-lactam antibiotics; clinical decision support system; antibiotic stewardship; hospitalized patients; infectious disease; antimicrobial prescribing; electronic medical record

Outcome Measures

Primary Outcomes (1)

• Proportion of patients receiving empirical beta-lactam antibiotics

  The primary outcome is the proportion of hospitalized patients with reported penicillin allergy who receive empirical treatment with beta-lactam antibiotics (penicillins or cephalosporins). The objective is to assess whether implementation of a digital clinical decision support tool increases beta-lactam use by 30% compared with the pre-implementation period.

  During hospital admission (up to discharge or day +30 after inclusion)

Secondary Outcomes (5)

• Adherence to hospital antibiotic treatment guidelines

  During hospital admission (up to discharge or day +30)

• Time to antibiotic treatment optimization according to hospital guidelines

  During hospital admission (up to discharge or day +30)

• Proportion of patients requiring hospital admission longer than 24 hours

  During hospital admission

• Incidence of antibiotic-related adverse reactions

  During treatment and up to day +30 after inclusion

• In-hospital and 30-day mortality

  Up to discharge and day +30 after inclusion

Study Arms (2)

Pre-implementation cohort

This cohort includes patients identified before the implementation of the digital clinical decision support tool. It consists of a retrospective collection of consecutive hospitalized patients older than 16 years treated at Hospital Sant Joan de Déu de Manresa (Althaia) for infections requiring systemic antibiotic therapy, who had a documented penicillin allergy label in the electronic medical record or reported a penicillin allergy during their clinical care. Patients in this cohort received standard clinical care without access to the digital decision support tool integrated into the electronic medical record. Antibiotic selection was based on routine clinical practice and existing hospital antimicrobial guidelines in place prior to the implementation of the tool. No study-specific intervention was applied in this cohort.

Post-implementation cohort

This cohort includes prospectively enrolled patients after the implementation of the digital clinical decision support tool integrated into the electronic medical record. It consists of consecutive hospitalized patients older than 16 years treated at Hospital Sant Joan de Déu de Manresa (Althaia) for infections requiring systemic antibiotic therapy, who have a documented penicillin allergy in the electronic medical record or report a penicillin allergy during the current admission. In this cohort, clinicians have access to a digital decision support tool integrated into the electronic medical record. The tool is structured as a decision tree based on the hospital's 2025 antibiotic guidelines and supports assessment of penicillin allergy risk and antibiotic selection. Antibiotic prescribing follows routine clinical practice supported by the tool. All participants provide informed consent prior to inclusion.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of hospitalized adult patients (aged 16 years or older) treated for infections requiring systemic antibiotic therapy, who have a documented or self-reported penicillin allergy. Participants are identified in a tertiary care hospital setting and include both patients treated before and after the implementation of a digital clinical decision support tool integrated into the electronic medical record.

You may qualify if:

• Age ≥ 16 years
• Hospitalized patients
• Diagnosis of infection requiring systemic antibiotic therapy
• Documented penicillin and/or cephalosporin allergy in the electronic medical record or self-reported allergy during current admission
• For the retrospective cohort: patients previously admitted to hospital or emergency department (≥16 hours) with a recorded penicillin allergy label
• Ability to understand study information and provision of written informed consent (prospective cohort only)

You may not qualify if:

• Patients with a reported penicillin allergy who do not require systemic antibiotic treatment
• Patients admitted to intensive care or intermediate care units
• Patients receiving outpatient hospital care or dialysis units
• Patients in end-of-life care or receiving palliative care
• Patients receiving antibiotics for surgical prophylaxis only

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead

Study Sites (1)

Hospital Sant Joan de Déu - Althaia

Manresa, Barcelona, 08243, Spain

Location

Related Publications (9)

• Su C, Belmont A, Liao J, Kuster JK, Trubiano JA, Kwah JH. Evaluating the PEN-FAST Clinical Decision-making Tool to Enhance Penicillin Allergy Delabeling. JAMA Intern Med. 2023 Aug 1;183(8):883-885. doi: 10.1001/jamainternmed.2023.1572.

  PMID: 37338869 BACKGROUND

• Piotin A, Godet J, Trubiano JA, Grandbastien M, Guenard-Bilbault L, de Blay F, Metz-Favre C. Predictive factors of amoxicillin immediate hypersensitivity and validation of PEN-FAST clinical decision rule. Ann Allergy Asthma Immunol. 2022 Jan;128(1):27-32. doi: 10.1016/j.anai.2021.07.005. Epub 2021 Jul 13.

  PMID: 34271183 BACKGROUND

• Trubiano JA, Vogrin S, Chua KYL, Bourke J, Yun J, Douglas A, Stone CA, Yu R, Groenendijk L, Holmes NE, Phillips EJ. Development and Validation of a Penicillin Allergy Clinical Decision Rule. JAMA Intern Med. 2020 May 1;180(5):745-752. doi: 10.1001/jamainternmed.2020.0403.

  PMID: 32176248 BACKGROUND

• Chua KYL, Vogrin S, Bury S, Douglas A, Holmes NE, Tan N, Brusco NK, Hall R, Lambros B, Lean J, Stevenson W, Devchand M, Garrett K, Thursky K, Grayson ML, Slavin MA, Phillips EJ, Trubiano JA. The Penicillin Allergy Delabeling Program: A Multicenter Whole-of-Hospital Health Services Intervention and Comparative Effectiveness Study. Clin Infect Dis. 2021 Aug 2;73(3):487-496. doi: 10.1093/cid/ciaa653.

  PMID: 32756983 BACKGROUND

• Sim I, Gorman P, Greenes RA, Haynes RB, Kaplan B, Lehmann H, Tang PC. Clinical decision support systems for the practice of evidence-based medicine. J Am Med Inform Assoc. 2001 Nov-Dec;8(6):527-34. doi: 10.1136/jamia.2001.0080527.

  PMID: 11687560 BACKGROUND

• Shenoy ES, Macy E, Rowe T, Blumenthal KG. Evaluation and Management of Penicillin Allergy: A Review. JAMA. 2019 Jan 15;321(2):188-199. doi: 10.1001/jama.2018.19283.

  PMID: 30644987 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

• 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

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Crespo-Casal, MD; PhD

  Fundació Althaia Xarxa Assistencial Universitària de Manresa

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: September 4, 2025
• Primary Completion: April 3, 2026
• Study Completion: April 3, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)