Anti-Infective AgentsAB-assistantNCT03793946
A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant
A study testing AB-assistant in people with Anti-Infective Agents and Mobile Applications, run by Annelies Verbon at 4 sites in 4 countries.
Trial summary
Optimal prescribing of antimicrobials is becoming increasingly challenging because of the growing complexity of guidelines and constantly changing distribution of infectious pathogens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Infective Agents, Mobile Applications, Quality Improvement
- What is being tested?
- AB-assistant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2020to Jan 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cluster level (wards):
- Medical and surgical wards.
- Physician level:
- All physicians involved in antibiotic prescribing decisions in the participating wards.
- Patient level:
- All patients hospitalized in the participating wards >= 18 years of age to whom systemic antimicrobials are prescribed.
Who cannot join
- Cluster level (wards):
- Outpatient clinics
- Psychiatry wards
- ICU
- Physician level:
- None
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- Patient level:
- None
- Treatment level:
- Surgical and medical prophylaxis.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Canada1 site
University of Calgary Cumming School of Medicine and Alberta Health Services, Department of Medicine
Calgary, Alberta, T2N 2TN
John Conly, Prof. Dr., john.conly@albertahealthservices.ca
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 CN
A Verbon, Prof. Dr., a.verbon@erasmusmc.nl
Sweden1 site
Uppsala University, Dept of Medical Sciences
Uppsala, 751 85
T Tängdén, MD, PhD, thomas.tangden@medsci.uu.se
Switzerland1 site
Geneva University Hospitals
Geneva, Canton of Geneva, 1211
B D Huttner, MD, MS, benedikt.huttner@hcuge.ch
G Catho, MD, MS
About this study
Official title: A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant: an International, Multicenter Stepped-wedge Cluster Randomized Trial
Optimal prescribing of antimicrobials is becoming increasingly challenging because of the growing complexity of guidelines and constantly changing distribution of infectious pathogens. Prescribing antimicrobials appropriately according to local guidelines optimizes therapy for the individual patient and reduces the emergence of resistance. By adapting and evaluating a smartphone based app containing local guidelines we aim to study appropriate prescribing of antimicrobials by physicians in three hospitals (Netherlands, Sweden and Switzerland).
Read the detailed description
Rationale: Antimicrobials are an indispensable part of modern medicine. However, optimal prescription of these agents is becoming increasingly challenging because of the growing complexity of guidelines, and constantly changing epidemiology of infectious pathogens. Moreover, due to local variations in the prevalence of certain pathogens and antimicrobial resistance (AMR), antimicrobial choices need to be tailored to local epidemiology. Improvement of antimicrobial use, in particular prevention of overuse and suboptimal use of antimicrobials, through antimicrobial stewardship (AMS) programs is increasingly regarded as indispensable, both to optimize therapy for the individual patients as well as to reduce emergence and spread of AMR. With the widespread use of electronic health records (EHR) and handheld electronic devices in hospitals, informatics-based AMS interventions hold great promise as tools to improve antimicrobial prescribing. However, they are still underdeveloped, understudied and underutilized.
Objective: The study aims to adapt and evaluate the "AB-assistant", a smartphone based digital stewardship application that is customizable to local guidelines by local antibiotic stewards and therefore has the potential to be used worldwide, including in low- and middle-income countries.
Study design: The existing North American Spectrum app (SpectrumMD; Canada) will be adjusted and translated for the European market. During a usability study physicians will use the app for two weeks followed by individual interviews to determine facilitators and barriers of app use. Based on the results of these interviews the app will be adjusted if necessary. After adaptation and usability testing, thereafter the AB-assistant app will be evaluated in an international, multicentre, randomized clinical trial involving centres in 3 countries in different settings with appropriate antimicrobial use as a primary outcome. In a stepped wedge cluster randomized trial, wards will be randomised after stratification for specialty. At baseline a 2-week measurement period will be done, followed by the introduction of the intervention to 6 wards (in 3 hospitals) with a 4-week interval with 6 inclusion periods. This cycle will be repeated with the inclusion of all new intervention wards. We include the 36 wards in total during the 6 inclusion phases and at the end of the inclusion time we allow use of the app by everyone, also wards not included in the study.
- Conditions
- Anti-Infective Agents, Mobile Applications, Quality Improvement, Antimicrobial Stewardship
- Being tested
- AB-assistant
- Keywords
- Drug Resistance, Microbial, Multicenter Study, Decision Support Systems, Clinical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-assistantOther
The AB-assistant is an antimicrobial stewardship smartphone application that offers local antimicrobial guidelines to physicians currently assessed per website or paper/digital booklet.
| Study group | Role | What they receive |
|---|---|---|
| AB-assistant | Experimental | Use of the AB-assistant app by physicians in intervention wards. Receives: Other: AB-assistant |
| Standard antimicrobial stewardship | No intervention | Physicians on these wards will use conventional ways to assess local guidelines to prescribe antimicrobials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate empirical antimicrobial therapy
According to predefined criteria
Measured: 12 months
Secondary outcomes (12)
Total prescription of antimicrobial drugs
In defined daily dose (DDD)/admission
Measured: 12 months
Total prescription of antimicrobial drugs per AWaRe category in DDD/admission
Per AWaRe category in DDD/admission
Measured: 12 months
Antimicrobial costs
Total costs of antimicrobial drugs administered
Measured: 12 months
Length of hospital stay (LOS)
(LOS)
Measured: 12 months
In-hospital mortality
All cause in-hospital mortality
Measured: 12 months
Hospital readmission within 30 days of discharge
Unplanned hospital readmissions within 30 days after discharge
Measured: 12 months
Transfer to intermediate care or ICU
% of admissions transferred to intermediate care or ICU after initial non-intermediate care or non-ICU admission
Measured: 12 months
Incidence Clostridium difficile infections (CDI)
Incidence of healthcare facility onset Clostridium difficile
Measured: 12 months
Incident clinical cultures with multi-drug resistant organisms (MDRO)
Incidence of clinical cultures with multidrug resistant organisms (methicillin-resistant Staphylococcus aureus (MRSA), Extended spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E), carbapenemase-producing Enterobacteriaceae (CPE), vancomycin-resistant enterococci (VRE), multidrug resistant P. aeruginosa) denominated per 1000 patient days and admissions
Measured: 12 months
Uptake of the AB-assistant
Total users and number of sessions per user, time spent per session, time spent per screen, number of times each screen is viewed.
Measured: 12 months
Actual use of AB-assistant and experiences while using it
Questionnaire
Measured: 12 months
Number of infectious diseases consultations
Total amount of infectious diseases consultations
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 posted4 Jan 2019
- Study startSep 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anti-Infective AgentsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- International, multicenter stepped-wedge cluster randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annelies Verbon
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center, University Hospital, Geneva, Uppsala University Hospital, University of Calgary
- Responsible party
- Sponsor-investigator, Annelies Verbon, Erasmus Medical Center
- Investigators
- B D Huttner, MD, MS, Principal investigator, University Hospital, GenevaT Tängdén, MD, PhD, Principal investigator, Uppsala UniversityJohn Conly, Prof. Dr., Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793946
- Sponsor's protocol ID
- ZonMw_549003001
- Acronym
- AB-assistant
- Status last verified
- Jul 2020
- First submitted
- 3 Jan 2019
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified raw data will be made publicly on request available from the time of publication or within a reasonable time period of the experiments being completed. General project data and metadata will be included in the supplementary data of published articles if needed and or shared through university repositories.
Publications
Helou RI, Catho G, Faxen L, Hulscher M, Teerenstra S, Conly J, Huttner BD, Tangden T, Verbon A. Impact of a smartphone application for appropriate antibiotic prescribing at three tertiary hospitals: an international, multicentre stepped-wedge cluster randomized trial. Clin Microbiol Infect. 2025 Jul;31(7):1172-1179. doi: 10.1016/j.cmi.2025.02.026. Epub 2025 Mar 1.
PubMed 40032084Helou RI, Catho G, Peyravi Latif A, Mouton J, Hulscher M, Teerenstra S, Conly J, Huttner BD, Tangden T, Verbon A. Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application. BMJ Open. 2020 Jun 4;10(6):e033640. doi: 10.1136/bmjopen-2019-033640.
PubMed 32503867
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant: an International, Multicenter Stepped-wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03793946
- Acronym / sponsor ID
- AB-assistant / ZonMw_549003001
- Conditions
- Anti-Infective Agents, Mobile Applications, Quality Improvement, Antimicrobial Stewardship
- Keywords
- Drug Resistance, Microbial, Multicenter Study, Decision Support Systems, Clinical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- Annelies VerbonUniversity, hospital or other
- Collaborators
- Erasmus Medical Center, University Hospital, Geneva, Uppsala University Hospital, University of Calgary
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 4 Jan 2019 (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.
Optimal prescribing of antimicrobials is becoming increasingly challenging because of the growing complexity of guidelines and constantly changing distribution of infectious pathogens. Prescribing antimicrobials appropriately according to local guidelines optimizes therapy for the individual patient and reduces the emergence of resistance. By adapting and evaluating a smartphone based app containing local guidelines we aim to study appropriate prescribing of antimicrobials by physicians in three hospitals (Netherlands, Sweden and Switzerland).
Detailed description
Rationale: Antimicrobials are an indispensable part of modern medicine. However, optimal prescription of these agents is becoming increasingly challenging because of the growing complexity of guidelines, and constantly changing epidemiology of infectious pathogens. Moreover, due to local variations in the prevalence of certain pathogens and antimicrobial resistance (AMR), antimicrobial choices need to be tailored to local epidemiology. Improvement of antimicrobial use, in particular prevention of overuse and suboptimal use of antimicrobials, through antimicrobial stewardship (AMS) programs is increasingly regarded as indispensable, both to optimize therapy for the individual patients as well as to reduce emergence and spread of AMR. With the widespread use of electronic health records (EHR) and handheld electronic devices in hospitals, informatics-based AMS interventions hold great promise as tools to improve antimicrobial prescribing. However, they are still underdeveloped, understudied and underutilized.
Objective: The study aims to adapt and evaluate the "AB-assistant", a smartphone based digital stewardship application that is customizable to local guidelines by local antibiotic stewards and therefore has the potential to be used worldwide, including in low- and middle-income countries.
Study design: The existing North American Spectrum app (SpectrumMD; Canada) will be adjusted and translated for the European market. During a usability study physicians will use the app for two weeks followed by individual interviews to determine facilitators and barriers of app use. Based on the results of these interviews the app will be adjusted if necessary. After adaptation and usability testing, thereafter the AB-assistant app will be evaluated in an international, multicentre, randomized clinical trial involving centres in 3 countries in different settings with appropriate antimicrobial use as a primary outcome. In a stepped wedge cluster randomized trial, wards will be randomised after stratification for specialty. At baseline a 2-week measurement period will be done, followed by the introduction of the intervention to 6 wards (in 3 hospitals) with a 4-week interval with 6 inclusion periods. This cycle will be repeated with the inclusion of all new intervention wards. We include the 36 wards in total during the 6 inclusion phases and at the end of the inclusion time we allow use of the app by everyone, also wards not included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- International, multicenter stepped-wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| AB-assistant | Experimental | Other: AB-assistantUse of the AB-assistant app by physicians in intervention wards. |
| Standard antimicrobial stewardship | No intervention | –Physicians on these wards will use conventional ways to assess local guidelines to prescribe antimicrobials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Medical and surgical wards.
- All physicians involved in antibiotic prescribing decisions in the participating wards.
- All patients hospitalized in the participating wards >= 18 years of age to whom systemic antimicrobials are prescribed.
Key exclusion criteria (10 listed)
- Outpatient clinics
- Psychiatry wards
- ICU
- None
- None
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 |
|---|---|---|
| AB-assistantThe AB-assistant is an antimicrobial stewardship smartphone application that offers local antimicrobial guidelines to physicians currently assessed per website or paper/digital booklet. | Other | AB-assistant |
Primary outcome
Appropriate empirical antimicrobial therapy
Time frame: 12 months
According to predefined criteria
12 secondary outcomes
Total prescription of antimicrobial drugs
Time frame: 12 months
Total prescription of antimicrobial drugs per AWaRe category in DDD/admission
Time frame: 12 months
Antimicrobial costs
Time frame: 12 months
Length of hospital stay (LOS)
Time frame: 12 months
In-hospital mortality
Time frame: 12 months
Hospital readmission within 30 days of discharge
Time frame: 12 months
Transfer to intermediate care or ICU
Time frame: 12 months
Incidence Clostridium difficile infections (CDI)
Time frame: 12 months
Incident clinical cultures with multi-drug resistant organisms (MDRO)
Time frame: 12 months
Uptake of the AB-assistant
Time frame: 12 months
Actual use of AB-assistant and experiences while using it
Time frame: 12 months
Number of infectious diseases consultations
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Derived from this study: PubMed 40032084Helou RI, Catho G, Faxen L, Hulscher M, Teerenstra S, Conly J, Huttner BD, Tangden T, Verbon A. Impact of a smartphone application for appropriate antibiotic prescribing at three tertiary hospitals: an international, multicentre stepped-wedge cluster randomized trial. Clin Microbiol Infect. 2025 Jul;31(7):1172-1179. doi: 10.1016/j.cmi.2025.02.026. Epub 2025 Mar 1.
- Derived from this study: PubMed 32503867Helou RI, Catho G, Peyravi Latif A, Mouton J, Hulscher M, Teerenstra S, Conly J, Huttner BD, Tangden T, Verbon A. Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application. BMJ Open. 2020 Jun 4;10(6):e033640. doi: 10.1136/bmjopen-2019-033640.
- Individual participant dataSharing planned: Yes. De-identified raw data will be made publicly on request available from the time of publication or within a reasonable time period of the experiments being completed. General project data and metadata will be included in the supplementary data of published articles if needed and or shared through university repositories.
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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.
B D Huttner, MD, MS principal investigator
University Hospital, Geneva
T Tängdén, MD, PhD principal investigator
Uppsala University
John Conly, Prof. Dr. principal investigator
University of Calgary
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AB-assistant in people with Anti-Infective Agents and Mobile Applications, run by Annelies Verbon at 4 sites in 4 countries.
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 10 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: status not confirmed, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Netherlands, Sweden, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R I Helou, MD (+31107033510, r.helou@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriate empirical antimicrobial therapy (time frame: 12 months). 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 NCT03793946, which also lists 2 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 4 Aug 2020.