NCT03793946

Brief Summary

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).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,080

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
4 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

January 3, 2019

Last Update Submit

July 31, 2020

Conditions

Keywords

Drug Resistance, MicrobialMulticenter StudyDecision Support Systems, Clinical

Outcome Measures

Primary Outcomes (1)

  • Appropriate empirical antimicrobial therapy

    According to predefined criteria

    12 months

Secondary Outcomes (12)

  • Total prescription of antimicrobial drugs

    12 months

  • Total prescription of antimicrobial drugs per AWaRe category in DDD/admission

    12 months

  • Antimicrobial costs

    12 months

  • Length of hospital stay (LOS)

    12 months

  • In-hospital mortality

    12 months

  • +7 more secondary outcomes

Study Arms (2)

AB-assistant

EXPERIMENTAL

Use of the AB-assistant app by physicians in intervention wards.

Other: AB-assistant

Standard antimicrobial stewardship

NO INTERVENTION

Physicians on these wards will use conventional ways to assess local guidelines to prescribe antimicrobials.

Interventions

The AB-assistant is an antimicrobial stewardship smartphone application that offers local antimicrobial guidelines to physicians currently assessed per website or paper/digital booklet.

AB-assistant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Cluster level (wards):
  • Outpatient clinics
  • Psychiatry wards
  • ICU
  • Physician level:
  • None
  • Patient level:
  • None
  • Treatment level:
  • Surgical and medical prophylaxis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Calgary Cumming School of Medicine and Alberta Health Services, Department of Medicine

Calgary, Alberta, T2N 2TN, Canada

Location

Erasmus Medical Center

Rotterdam, South Holland, 3015 CN, Netherlands

Location

Uppsala University, Dept of Medical Sciences

Uppsala, 751 85, Sweden

Location

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (2)

  • 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.

  • Helou 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.

Study Officials

  • B D Huttner, MD, MS

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR
  • T Tängdén, MD, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR
  • John Conly, Prof. Dr.

    University of Calgary Cumming School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

A Verbon, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking of care providers and investigators is not feasible. Outcome assessors and data analysts will be blinded to the study arm allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: International, multicenter stepped-wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 4, 2019

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

January 1, 2022

Last Updated

August 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, CSR

Locations