Penicillin AllergyDigitalpenNCT07604597
A Digital Stewardship Strategy for Patients With Reported Penicillin Allergy
An observational study of Penicillin Allergy and In-hospital Process Optimization, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Penicillin Allergy, In-hospital Process Optimization
- How many people
- 182 participants
- Where
- 1 siteSpain
- Study dates
- 4 Sep 2025to 3 Apr 2026
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Antibiotic Treatment in Patients With a Reported Penicillin Allergy Using a Digital Clinical Decision Support Tool.
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.
Read more
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.
Read the detailed description
Study design and setting
This is a prospective, open-label, single-center study conducted at Hospital Sant Joan de Déu de Manresa (Althaia University Healthcare Network). The study evaluates the implementation of a digital clinical decision support tool integrated into the electronic medical record (EMR) to optimize antibiotic prescribing in hospitalized patients with a reported penicillin allergy.
The study includes two phases:
Pre-implementation phase
A retrospective cohort is used to describe antibiotic prescribing patterns in patients meeting eligibility criteria before implementation of the digital tool. Patients are identified through a digital EMR filter implemented in March 2024 that detects hospitalized patients or emergency department visits longer than 16 hours with a recorded penicillin allergy label.
Post-implementation phase
A prospective cohort includes consecutive eligible patients after implementation of the digital decision support tool. Patients are included after providing informed consent.
Intervention and implementation strategy
The intervention consists of a digital decision support tool integrated into the EMR. The tool is structured as a decision tree adapted from the hospital's 2025 adult empirical antibiotic treatment guideline.
The tool systematically evaluates the individual risk of penicillin allergy and provides recommendations to support antibiotic selection according to hospital guidelines.
Implementation includes:
- Training sessions for emergency department physicians, who are the main prescribers of empirical antibiotics in this population.
- Hospital-wide dissemination campaign through EMR communication channels to promote awareness and use of the tool.
Study population and data collection
The study includes patients older than 16 years treated at the hospital for infections requiring systemic antibiotic therapy who:
- Have a documented penicillin allergy in the EMR, or
- Report a penicillin allergy during the current admission.
Data collected include:
- Demographic variables (age, sex).
- Clinical setting (emergency, medical, surgical, obstetric/gynecological, day hospital, dialysis units).
- Infection focus (respiratory, urinary, abdominal, skin/soft tissue, bloodstream infection, osteoarticular, central nervous system).
- Characteristics of reported penicillin allergy, including timing and type of reaction (immediate, delayed, immunological or non-immunological reactions).
- Allergy risk stratification using the PEN-FAST score.
- History of allergy to non-beta-lactam antibiotics.
Antibiotic treatment variables.
Antibiotic prescribing is recorded for empirical and modified treatments, including:
- Beta-lactams (penicillins, cephalosporins, carbapenems, monobactams).
- Alternative antibiotics (fluoroquinolones, glycopeptides, lipopeptides, oxazolidinones, aminoglycosides, lincosamides, sulfonamides, macrolides).
Data include:
- Start and end dates of empirical and modified antibiotic therapy.
- Treatment modifications and reasons (guideline adherence, targeted therapy, adverse reactions).
- Final antibiotic regimen after modification.
Outcomes and follow-up
Patients are followed until hospital discharge or day +30 after inclusion.
Outcomes include:
- Antibiotic prescribing patterns, including beta-lactam use.
- Guideline-concordant empirical therapy.
- Adverse drug reactions to beta-lactams.
- Changes in allergy label status after clinical evaluation.
- Hospital length of stay.
- In-hospital mortality and 30-day status (discharge, hospitalization, death).
Data management and statistical analysis
Data are collected in a secure REDCap database hosted by the institution.
Statistical analysis is performed using SPSS version 26. Categorical variables are expressed as frequencies and percentages. Continuous variables are expressed as mean ± standard deviation or median with interquartile range, depending on distribution. Normality is assessed using the Kolmogorov-Smirnov test.
Group comparisons are performed using chi-square or Fisher's exact test for categorical variables, and t-test or rank-sum test for continuous variables. Confidence intervals at 95% are reported for primary and secondary outcomes.
Study timeline
The study includes:
- Pre-implementation retrospective cohort
- Development and implementation of the digital tool
- Training and dissemination phase
- Prospective post-implementation recruitment
- Final data analysis and dissemination of results
Total study duration is 15 months.
Ethics and data protection
The study has been approved by the institutional ethics committee. It is conducted in accordance with the Declaration of Helsinki (2024 revision), Good Clinical Practice guidelines, and applicable Spanish and European data protection regulations (EU Regulation 2016/679 and Organic Law 3/2018).
All patient data are pseudonymized and stored securely. Retrospective data use is performed under applicable legal provisions for research use of pseudonymized health data without informed consent when authorized by the ethics committee.
Quality assurance and implementation procedures
The study includes EMR-based data validation and structured data extraction. The digital tool implementation is supported by clinician training and institutional communication strategies to ensure correct use and adherence.
Expected impact
The study aims to improve antibiotic prescribing in patients with reported penicillin allergy by increasing appropriate use of beta-lactam antibiotics, improving adherence to institutional guidelines, enhancing allergy documentation, and potentially reducing hospital length of stay.
- Keywords
- penicillin allergy, beta-lactam antibiotics, clinical decision support system, antibiotic stewardship, hospitalized patients, infectious disease, antimicrobial prescribing, electronic medical record
- Medical subject headings
- Communicable Diseases
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During hospital admission (up to discharge or day +30 after inclusion)
Secondary outcomes (5)
Adherence to hospital antibiotic treatment guidelines
Comparison of the proportion of patients receiving empirical antibiotic therapy consistent with the hospital's antimicrobial treatment guidelines before and after implementation of the digital decision support tool.
Measured: During hospital admission (up to discharge or day +30)
Time to antibiotic treatment optimization according to hospital guidelines
Time elapsed from initiation of empirical antibiotic therapy to adjustment according to guideline-recommended treatment.
Measured: During hospital admission (up to discharge or day +30)
Proportion of patients requiring hospital admission longer than 24 hours
Percentage of patients requiring hospitalization exceeding 24 hours during the index infection episode.
Measured: During hospital admission
Incidence of antibiotic-related adverse reactions
Incidence and classification of adverse reactions associated with antibiotic therapy, including immediate, delayed, and non-immunologically mediated reactions.
Measured: During treatment and up to day +30 after inclusion
In-hospital and 30-day mortality
All-cause mortality during hospital admission and within 30 days after inclusion.
Measured: Up to discharge and day +30 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start4 Sep 2025
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Penicillin AllergyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Crespo-Casal, MD; PhD, Principal investigator, Fundació Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604597
- Sponsor's protocol ID
- 25/066
- Acronym
- Digitalpen
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37338869Piotin 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.
PubMed 34271183Trubiano 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.
PubMed 32176248Chua 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.
PubMed 32756983Sim 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.
PubMed 11687560Shenoy 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.
PubMed 30644987Romano 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 31749148Inglis 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 28742226Blumenthal 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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Antibiotic Treatment in Patients With a Reported Penicillin Allergy Using a Digital Clinical Decision Support Tool.
- ClinicalTrials.gov ID
- NCT07604597
- Acronym / sponsor ID
- Digitalpen / 25/066
- Keywords
- penicillin allergy, beta-lactam antibiotics, clinical decision support system, antibiotic stewardship, hospitalized patients, infectious disease, antimicrobial prescribing, electronic medical record
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 22 May 2026 (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 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.
Detailed description
Study design and setting
This is a prospective, open-label, single-center study conducted at Hospital Sant Joan de Déu de Manresa (Althaia University Healthcare Network). The study evaluates the implementation of a digital clinical decision support tool integrated into the electronic medical record (EMR) to optimize antibiotic prescribing in hospitalized patients with a reported penicillin allergy.
The study includes two phases:
Pre-implementation phase
A retrospective cohort is used to describe antibiotic prescribing patterns in patients meeting eligibility criteria before implementation of the digital tool. Patients are identified through a digital EMR filter implemented in March 2024 that detects hospitalized patients or emergency department visits longer than 16 hours with a recorded penicillin allergy label.
Post-implementation phase
A prospective cohort includes consecutive eligible patients after implementation of the digital decision support tool. Patients are included after providing informed consent.
Intervention and implementation strategy
The intervention consists of a digital decision support tool integrated into the EMR. The tool is structured as a decision tree adapted from the hospital's 2025 adult empirical antibiotic treatment guideline.
The tool systematically evaluates the individual risk of penicillin allergy and provides recommendations to support antibiotic selection according to hospital guidelines.
Implementation includes:
- Training sessions for emergency department physicians, who are the main prescribers of empirical antibiotics in this population.
- Hospital-wide dissemination campaign through EMR communication channels to promote awareness and use of the tool.
Study population and data collection
The study includes patients older than 16 years treated at the hospital for infections requiring systemic antibiotic therapy who:
- Have a documented penicillin allergy in the EMR, or
- Report a penicillin allergy during the current admission.
Data collected include:
- Demographic variables (age, sex).
- Clinical setting (emergency, medical, surgical, obstetric/gynecological, day hospital, dialysis units).
- Infection focus (respiratory, urinary, abdominal, skin/soft tissue, bloodstream infection, osteoarticular, central nervous system).
- Characteristics of reported penicillin allergy, including timing and type of reaction (immediate, delayed, immunological or non-immunological reactions).
- Allergy risk stratification using the PEN-FAST score.
- History of allergy to non-beta-lactam antibiotics.
Antibiotic treatment variables.
Antibiotic prescribing is recorded for empirical and modified treatments, including:
- Beta-lactams (penicillins, cephalosporins, carbapenems, monobactams).
- Alternative antibiotics (fluoroquinolones, glycopeptides, lipopeptides, oxazolidinones, aminoglycosides, lincosamides, sulfonamides, macrolides).
Data include:
- Start and end dates of empirical and modified antibiotic therapy.
- Treatment modifications and reasons (guideline adherence, targeted therapy, adverse reactions).
- Final antibiotic regimen after modification.
Outcomes and follow-up
Patients are followed until hospital discharge or day +30 after inclusion.
Outcomes include:
- Antibiotic prescribing patterns, including beta-lactam use.
- Guideline-concordant empirical therapy.
- Adverse drug reactions to beta-lactams.
- Changes in allergy label status after clinical evaluation.
- Hospital length of stay.
- In-hospital mortality and 30-day status (discharge, hospitalization, death).
Data management and statistical analysis
Data are collected in a secure REDCap database hosted by the institution.
Statistical analysis is performed using SPSS version 26. Categorical variables are expressed as frequencies and percentages. Continuous variables are expressed as mean ± standard deviation or median with interquartile range, depending on distribution. Normality is assessed using the Kolmogorov-Smirnov test.
Group comparisons are performed using chi-square or Fisher's exact test for categorical variables, and t-test or rank-sum test for continuous variables. Confidence intervals at 95% are reported for primary and secondary outcomes.
Study timeline
The study includes:
- Pre-implementation retrospective cohort
- Development and implementation of the digital tool
- Training and dissemination phase
- Prospective post-implementation recruitment
- Final data analysis and dissemination of results
Total study duration is 15 months.
Ethics and data protection
The study has been approved by the institutional ethics committee. It is conducted in accordance with the Declaration of Helsinki (2024 revision), Good Clinical Practice guidelines, and applicable Spanish and European data protection regulations (EU Regulation 2016/679 and Organic Law 3/2018).
All patient data are pseudonymized and stored securely. Retrospective data use is performed under applicable legal provisions for research use of pseudonymized health data without informed consent when authorized by the ethics committee.
Quality assurance and implementation procedures
The study includes EMR-based data validation and structured data extraction. The digital tool implementation is supported by clinician training and institutional communication strategies to ensure correct use and adherence.
Expected impact
The study aims to improve antibiotic prescribing in patients with reported penicillin allergy by increasing appropriate use of beta-lactam antibiotics, improving adherence to institutional guidelines, enhancing allergy documentation, and potentially reducing hospital length of stay.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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
Proportion of patients receiving empirical beta-lactam antibiotics
Time frame: During hospital admission (up to discharge or day +30 after inclusion)
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.
5 secondary outcomes
Adherence to hospital antibiotic treatment guidelines
Time frame: During hospital admission (up to discharge or day +30)
Time to antibiotic treatment optimization according to hospital guidelines
Time frame: During hospital admission (up to discharge or day +30)
Proportion of patients requiring hospital admission longer than 24 hours
Time frame: During hospital admission
Incidence of antibiotic-related adverse reactions
Time frame: During treatment and up to day +30 after inclusion
In-hospital and 30-day mortality
Time frame: Up to discharge and day +30 after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 37338869Su 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.
- Background: PubMed 34271183Piotin 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.
- Background: PubMed 32176248Trubiano 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.
- Background: PubMed 32756983Chua 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.
- Background: PubMed 11687560Sim 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.
- Background: PubMed 30644987Shenoy 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.
- 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 30558872Blumenthal 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.
- 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.
Manuel Crespo-Casal, MD; PhD principal investigator
Fundació Althaia Xarxa Assistencial Universitària de Manresa
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 Penicillin Allergy and In-hospital Process Optimization, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 29 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 receiving empirical beta-lactam antibiotics (time frame: During hospital admission (up to discharge or day +30 after inclusion)). 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 NCT07604597, which also lists 9 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 29 May 2026.