Antibiotic PrescriptionsTARGETNCT07115966
Impact of a Simple Automated Best Practice Alert (BPA) on Quantity and Quality of In-hospital Antibiotic Use in a Tertiary and Three Secondary Hospitals
A study testing Computerized decision support by best practice alert (BPA) in people with Antibiotic Prescriptions and In-Patient Treatment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The goal of the stepped-wedge cluster-randomized trial is to assess the impact of an antimicrobial stewardship intervention: a simple, automated Best Practice Alert (BPA) that reminds prescribers to reevaluate antibiotic therapy after 72 hours (or 24 hours for prophylaxis), in accordance with guideline… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antibiotic Prescriptions, In-Patient Treatment
- What is being tested?
- Computerized decision support by best practice alert (BPA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All inpatient wards with at least 50 PA/year, except those listed in the exclusion criteria
Who cannot join
- Ward level:
- Emergency departments
- Outpatient clinics
- Haemato-oncologic stem cell transplant wards, where daily ID visits are performed
- ICU wards, where daily ID visits are performed
- Indvidual patient data for analysis
- Refusal of institutional general consent for further use of patient data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Simple Automated Best Practice Alert (BPA) on Quantity and Quality of In-hospital Antibiotic Use - a Stepped-wedge, Cluster Randomized, Controlled Trial
The goal of the stepped-wedge cluster-randomized trial is to assess the impact of an antimicrobial stewardship intervention: a simple, automated Best Practice Alert (BPA) that reminds prescribers to reevaluate antibiotic therapy after 72 hours (or 24 hours for prophylaxis), in accordance with guideline recommendations. The primary hypothesis is that this simple BPA reduces antibiotic use in terms of quantity (amount and duration) and quality (spectrum breadth), measured by days of antibiotic spectrum coverage at the patient level (primary outcome), as well as at both patient and cluster levels using various metrics of antibiotic use. The trial will introduce the BPA in a stepwise manner, with all wards implementing it by the end. It will compare the intervention period to the baseline (pre-intervention) and control periods.
- Conditions
- Antibiotic Prescriptions, In-Patient Treatment
- Being tested
- Computerized decision support by best practice alert (BPA)
- Keywords
- best practice alert, quanlity and quantity of antibiotic use, in-patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized decision support by best practice alert (BPA)Behavioural
The antimicrobial stewardship intervention encourages prescribers by a simple alert to follow guidelines for reviewing antimicrobial prescriptions after a set timeframe for potential de-escalation to targeted therapy or discontinuation of the antibiotics, as recommended by national and international guidelines.
An automated simple BPA will trigger after an antibiotic prescription with therapeutic indication (72 hours) or surgical prophylaxis (24 hours, reminding prescribers to reassess treatment for possible de-escalation, adaption to targeted therapy, or cessation.
If ignored, the prescription remains unchanged, but the alert will continue until addressed. Prescribers must select reasons for not changing the prescription, such as pending microbiology results. The control group corresponds to the inpatient wards not yet receiving the BPA, where antibiotics are managed according to "standard-of-care".
| Study group | Role | What they receive |
|---|---|---|
| Best practice alert (BPA) | Experimental | Intervention:
The BPA will appear to the prescribing physician for every patient on the respective ward.
Activation of the BPA is ward-based.
A total of 58 wards will be stratified according to their focus-surgical, medical, intermediate care, rehabilitation, or pediatric-and grouped based on their baseline antibiotic consumption, measured in days of antibiotic spectrum coverage per patient admission (DASC/PA). This stratification will result in 9 to 10 clusters across 6 groups.
The clusters will then be randomized to the timing of BPA activation, and all wards will sequentially switch to the BPA arm every 2 months over a 12-month period.
By the end of the trial, after 12 months, all wards will be using the automated BPA. Receives: Behavioral: Computerized decision support by best practice alert (BPA) |
| Controls - No BPA | No intervention | Control: standard patient care with no BPA activated. By the end of the trial, after 12 months, all wards will be using the automated BPA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of antibiotic spectrum coverage (DASC) per patient admission (PA)
Overall score of days of antibiotic spectrum coverage per patient admission. The score is composed of the breadth of the bacterial spectrum covered by the administered antibiotic (according to Kakiuchi 2022 - the broader the antibiotic spectrum, the higher the score), summed over the number of days the antibiotic is given. Accordingly, there are no maximum or minimum values
Measured: 12 months
Secondary outcomes (11)
Days of antibiotic spectrum coverage (DASC) per patient antibiotic day (PAD)
Overall score of antibiotic spectrum coverage per patient antibiotic day. The score is composed of the breadth of the bacterial spectrum covered by the administered antibiotic (according to Kakiuchi 2022 - the broader the antibiotic spectrum, the higher the score), summed over the number of days the antibiotic is given. Accordingly, there are no maximum or minimum values.
Measured: 12 months
Days of treatment (DOT) per 100 patient days (PD) and per patient admission on ward level
Overall days of treatment (DOT) per 100 patient days (PD) and per patient admission (PA) on ward level
Measured: 12 months
Defined daily doses (DDD) per 100 patient days (PD) and per patient admission (PA)
Overall defined daily doses) per 100 patient days (PD) and per patient admission (PA) on ward level. Standard metrics recommended by WHO for international benchmarking.
Measured: 12 months
Antibiotic (AB) days per patient admission (PA)
No of days an AB per PA gives the proportion of days antibiotics have been applicated, irrespective of single, double, triple combinations, in relation to total PA
Measured: 12 months
In hospital mortality
All cause in hospital mortality
Measured: 12 months
Hospital length of stay (LOS)
Measured: 12 months
Unplanned readmission within first 30 days after discharge
Measured: 12 months
Patient admission to IMC/ICU from studied wards
Number and proportion of patient admissions to IMC/ICU from studied wards
Measured: 12 months
Number of Infectious diseases (ID) consultation per patient admission (PA)
Measured: 12 months
In hospital C. difficile infection incidence within hospital stay per patient admission (PA) and per 100 patient days (PD)
Measured: 12 months
Inhospital incidence of multi-drug-resistant-organisms (MDRO) detection per100 patient days (PD) or per patient admission (PA)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Aug 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic PrescriptionsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Wards will be cluster-randomized according to specialty and antibiotic use (DASC/PA), based on retrospective data. The BPA will be activated in a stepwise manner for each cluster every two months over a 12-month period. By the end of the study, the BPA will be active in all participating wards.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Jent, PD, Study chair, Inselgruppe BernNasstasja Wassilew, Dr. med., Principal investigator, Inselgruppe Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115966
- Sponsor's protocol ID
- 2025-00735
- Other IDs
- 2025
- Acronym
- TARGET
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Simple Automated Best Practice Alert (BPA) on Quantity and Quality of In-hospital Antibiotic Use - a Stepped-wedge, Cluster Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07115966
- Acronym / sponsor ID
- TARGET / 2025-00735
- Conditions
- Antibiotic Prescriptions, In-Patient Treatment
- Keywords
- best practice alert, quanlity and quantity of antibiotic use, in-patients
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 11 Aug 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.
The goal of the stepped-wedge cluster-randomized trial is to assess the impact of an antimicrobial stewardship intervention: a simple, automated Best Practice Alert (BPA) that reminds prescribers to reevaluate antibiotic therapy after 72 hours (or 24 hours for prophylaxis), in accordance with guideline recommendations. The primary hypothesis is that this simple BPA reduces antibiotic use in terms of quantity (amount and duration) and quality (spectrum breadth), measured by days of antibiotic spectrum coverage at the patient level (primary outcome), as well as at both patient and cluster levels using various metrics of antibiotic use. The trial will introduce the BPA in a stepwise manner, with all wards implementing it by the end. It will compare the intervention period to the baseline (pre-intervention) and control periods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Wards will be cluster-randomized according to specialty and antibiotic use (DASC/PA), based on retrospective data. The BPA will be activated in a stepwise manner for each cluster every two months over a 12-month period. By the end of the study, the BPA will be active in all participating wards.
| Arm | Type | Receives |
|---|---|---|
| Best practice alert (BPA) | Experimental | Behavioral: Computerized decision support by best practice alert (BPA)Intervention: The BPA will appear to the prescribing physician for every patient on the respective ward. Activation of the BPA is ward-based. A total of 58 wards will be stratified according to their focus-surgical, medical, intermediate care, rehabilitation, or pediatric-and grouped based on their baseline antibiotic consumption, measured in days of antibiotic spectrum coverage per patient admission (DASC/PA). This stratification will result in 9 to 10 clusters across 6 groups. The clusters will then be randomized to the timing of BPA activation, and all wards will sequentially switch to the BPA arm every 2 months over a 12-month period. By the end of the trial, after 12 months, all wards will be using the automated BPA. |
| Controls - No BPA | No intervention | –Control: standard patient care with no BPA activated. By the end of the trial, after 12 months, all wards will be using the automated BPA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All inpatient wards with at least 50 PA/year, except those listed in the exclusion criteria
Key exclusion criteria (7 listed)
- Emergency departments
- Outpatient clinics
- Haemato-oncologic stem cell transplant wards, where daily ID visits are performed
- ICU wards, where daily ID visits are performed
- Indvidual patient data for analysis
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 |
|---|---|---|
| Computerized decision support by best practice alert (BPA)The antimicrobial stewardship intervention encourages prescribers by a simple alert to follow guidelines for reviewing antimicrobial prescriptions after a set timeframe for potential de-escalation to targeted therapy or discontinuation of the antibiotics, as recommended by national and international guidelines. An automated simple BPA will trigger after an antibiotic prescription with therapeutic indication (72 hours) or surgical prophylaxis (24 hours, reminding prescribers to reassess treatment for possible de-escalation, adaption to targeted therapy, or cessation. If ignored, the prescription remains unchanged, but the alert will continue until addressed. Prescribers must select reasons for not changing the prescription, such as pending microbiology results. The control group corresponds to the inpatient wards not yet receiving the BPA, where antibiotics are managed according to "standard-of-care". | Behavioural | Best practice alert (BPA) |
Primary outcome
Days of antibiotic spectrum coverage (DASC) per patient admission (PA)
Time frame: 12 months
Overall score of days of antibiotic spectrum coverage per patient admission. The score is composed of the breadth of the bacterial spectrum covered by the administered antibiotic (according to Kakiuchi 2022 - the broader the antibiotic spectrum, the higher the score), summed over the number of days the antibiotic is given. Accordingly, there are no maximum or minimum values
11 secondary outcomes
Days of antibiotic spectrum coverage (DASC) per patient antibiotic day (PAD)
Time frame: 12 months
Days of treatment (DOT) per 100 patient days (PD) and per patient admission on ward level
Time frame: 12 months
Defined daily doses (DDD) per 100 patient days (PD) and per patient admission (PA)
Time frame: 12 months
Antibiotic (AB) days per patient admission (PA)
Time frame: 12 months
In hospital mortality
Time frame: 12 months
Hospital length of stay (LOS)
Time frame: 12 months
Unplanned readmission within first 30 days after discharge
Time frame: 12 months
Patient admission to IMC/ICU from studied wards
Time frame: 12 months
Number of Infectious diseases (ID) consultation per patient admission (PA)
Time frame: 12 months
In hospital C. difficile infection incidence within hospital stay per patient admission (PA) and per 100 patient days (PD)
Time frame: 12 months
Inhospital incidence of multi-drug-resistant-organisms (MDRO) detection per100 patient days (PD) or per patient admission (PA)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- 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.
Philipp Jent, PD study chair
Inselgruppe Bern
Nasstasja Wassilew, Dr. med. principal investigator
Inselgruppe Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized decision support by best practice alert (BPA) in people with Antibiotic Prescriptions and In-Patient Treatment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Days of antibiotic spectrum coverage (DASC) per patient admission (PA) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.