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NCT Number: NCT04001309

Antimicrobial Stewardship Interventions in a Hospital Setting

The emerging crisis of multidrug-resistant bacteria is accelerated by a massive overuse and misuse of antibiotics. It has been estimated that 50% of antibiotic prescriptions are inappropriate. Antibiotic interventions to improve prescribing patterns have been successfully implemented in primary care in Sweden and other countries. However, much of the last-resort antibiotics are used in hospitals in which decisions on therapy for bacterial infections are more complex. In this project we will explore the appropriateness of antibiotic prescribing in a hospital setting and measures to improve the quality of antimicrobial therapy. Antimicrobial stewardship interventions will be conducted at selected hospital departments using prospective audit and feedback in a multifaceted and cross-disciplinary approach. The intervention effects on antibiotic consumption, appropriateness of prescriptions, patient outcome and emergence of resistance will be evaluated, and a financial cost-effectiveness analysis will be performed.

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Key information

Conditions

Infectious Disease Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital, Uppsala, Sweden

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About this study

Background: In this project we will address the issue of inappropriate antibiotic prescribing in a hospital setting using a systematic and cross-disciplinary approach. We believe that a substantial reduction in antibiotic use and a significant improvement in prescribing patterns can be achieved, which will benefit the patients by reducing the risks of side effects such as antibiotic-induced Clostridium difficile enteritis.

Aim: The aim of this study is to implement and evaluate antibiotic interventions at targeted hospital wards.

Method: Hospital wards will be randomised to one of two antimicrobial stewardship intervention arms stratified by specialty (medicine or surgery). Prospective audit and feedback is a core intervention strategy in both arms.

Statistics: Interrupted time-series analysis (ITS) will be used for the primary endpoint; volume of antimicrobial prescribing. Monthly baseline data at least five years prior to start of the intervention and a during a follow-up period of at least 12 months after end of the intervention period will be used to assess immediate and sustained effects.

Endpoints and outcomes:

  • Primary endpoint is reduction in antibiotic use, days of antibiotic therapy (DOTs)/100 patient days
  • Secondary endpoints include outcome measures for quantity of antibiotic use, appropriateness of prescriptions, clinical and microbiological outcome and cost-effectiveness.

Data on antibiotic use and trends in prescriptions of key antibiotics will be obtained from hospital pharmacies. Data on duration of hospitalization, patient mortality, re-admissions and side effects including antibiotic-associated Clostridium difficile enteritis will be extracted from the medical records to assess potential impact on patient outcome caused by the intervention. Data on emergence of resistance during therapy and general trends in resistance epidemiology will be recorded. The outcome assessment will include a survey to participating physicians on the value different aspects of the stewardship intervention in their daily care of patients with infections. A cost-effectiveness analysis of the intervention will be performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Randomization to intervention arms is performed on ward level.

Eligibility criteria:

  • Surgical or medical wards

Patient level (too be included in the outcome analyses)

Inclusion criteria

  • At least 18 years of age
  • Ongoing antimicrobial therapy on a study ward
  • Signed informed consent

Exclusion criteria

  • Patients in palliative care with very short life expectancy
  • Patients from another county than study site

Treatment and study plan

Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions

Other

Prospective audit and feedback of antimicrobial therapy at hospital wards, by interventions performed by infectious diseases specialists alone or using a team-based approach.

Primary outcomes

  1. Change and trends in days of antibiotic therapy (DOT)/100 patient days

    Time frame: 7 years

    Monthly DOT of antibiotics per 100 patient days on ward level assessed 5 y pre-intervention and 1 y post-intervention. Data will be analysed using interrupted time series analysis to assess immediate changes following implementation and comparison of trends before and after the intervention.

Secondary outcomes

  1. Days of defined daily doses (DDDs)/100 patient days

    Time frame: 12 months

    Overall days of therapy per 100 patient days (PD) on the ward level

  2. Treatment duration (Days per treatment period overall)

    Time frame: 12 months

    Overall days per treatment episode. A treatment episode is defined as antimicrobial treatment not interrupted by more than one calendar day.

  3. 30-d mortality

    Time frame: 12 months

    All cause 30-d mortality

  4. In-hospital mortality

    Time frame: 12 months

    All-cause in-hospital mortality

  5. Hospital readmission within 30 d after discharge

    Time frame: 12 months

    Unplanned hospital readmission within 30 d after discharge

  6. Hospital readmission due to relapse of infection within 30 d after discharge

    Time frame: 12 months

    Unplanned hospital readmission due to relapse of infection within 30 d after discharge

  7. Hospital length of stay (LOS)

    Time frame: 12 months

    Hospital length of stay per admission

  8. Intensive Care Unit (ICU) transfer

    Time frame: 12 months

    Proportion of admissions transferred to ICU after initial non-ICU admission

  9. Guideline compliance

    Time frame: 12 months

    Proportion of patients treated where antimicrobial therapy was in compliance with local guideline, or in absence of local guideline national guideline

  10. De-escalation or shift to targeted therapy

    Time frame: 12 months

    Proportion of patients where de-escalation or shift to targeted antibiotic therapy occurred within 72 hours after initiation of treatment

  11. Intravenous to oral switch

    Time frame: 12 months

    Proportion of patients where intravenous antibiotics was shifted to oral therapy within 5 days (if appropriate)

  12. Appropriate diagnostic examinations

    Time frame: 12 months

    Proportion of patients with appropriate diagnostic examinations performed, according to local guidelines, or in the absence of local guidelines national guidelines

  13. Dose adjustment for renal function within 48 h after initiation of antimicrobial therapy at admission

    Time frame: 12 months

    Dose adjustment of antimicrobial after the most critical phase of the infection

  14. Dose adjustment for renal function when initiating antimicrobial therapy in a non-acute situation

    Time frame: 12 months

    Proportion of antimicrobial prescription in non-acute situations where dosing was according to renal function

  15. Therapeutic drug monitoring (TDM)

    Time frame: 12 months

    Proportion of patients where TDM was used, when applicable according to local guideline

  16. Drug-drug interactions (DDI)

    Time frame: 12 months

    Important DDI taken into account when prescribing antimicrobial therapy

  17. Incidence of Clostridium difficile infections (CDI)

    Time frame: 12 months

    Incidence of healthcare-facility onset CDI denominated by 10 000 PD and admission

  18. Incidence of multidrug-resistant organisms (MDRO)

    Time frame: 12 months

    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 PD and admissions

  19. Costs of administered antimicrobials

    Time frame: 12 months

    Costs of administered antimicrobials (overall and by class) per admission and per patient receiving antibiotics

  20. Costs of the intervention

    Time frame: 12 months

    Total costs of the intervention

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Lund University

Registry information

Official study title

A Randomized Antimicrobial Stewardship Trial in a Hospital Setting

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2019
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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