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Trial record 11 of 11559 for:    Anti-Infective Agents AND antibacterial

Antimicrobial Stewardship Interventions in a Hospital Setting

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ClinicalTrials.gov Identifier: NCT04001309
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Tängdén, Uppsala University

Brief Summary:
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-benefit analysis will be performed.

Condition or disease Intervention/treatment Phase
Infectious Disease Other: Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions Not Applicable

Detailed Description:

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, defined daily doses (DDD)/100 patient days
  • Secondary endpoints include outcome measures for 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. A cost-benefit analysis of the intervention will be performed.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: Masking for care providers and investigators is not feasible. Outcomes assessors will be blinded to study period and intervention arms when evaluating appropriateness of prescribing.
Primary Purpose: Treatment
Official Title: A Randomized Antimicrobial Stewardship Trial in a Hospital Setting
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Infectious diseases physician led

Prospective audit and feedback of antimicrobial therapy by infectious disease physicians twice weekly

Also including standard of care

  • infectious disease consultant on demand
  • hospital antimicrobial stewardship program as usual (education, general information, feedback on prescribing)
Other: Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions
Prospective audit and feedback of antimicrobial therapy at hospital wards, by interventions performed by infectious diseases specialists alone or using a team-based approach.

Experimental: Multiprofessional team

Prospective audit and feedback of antimicrobial therapy by infectious disease physicians once weekly, ward clinical pharmacists thrice weekly and engagement of ward nurses in the stewardship intervention

Also including standard of care

  • infectious disease consultant on demand
  • hospital antimicrobial stewardship program as usual (education, general information, feedback on prescribing)
Other: Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions
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 Outcome Measures :
  1. Change and trends in defined daily doses (DDDs) of antibiotics/100 patient days [ Time Frame: 7 years ]
    Monthly DDDs 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 Outcome Measures :
  1. Days of antimicrobial therapy (DOT)/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 antibimicrobial 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001309


Contacts
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Contact: Thomas Tängdén, MD, Phd +46708370323 thomas.grenholm.tangden@medsci.uu.se
Contact: Annabel Peyravi Latif, MSc +46709451880 annabel.peyravi.latif@medci.uu.se

Locations
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Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Thomas Tängdén, MD, PhD    +46186110000    thomas.tangden@medsci.uu.se   
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Thomas Tängdén, MD, Phd Uppsala University Hospital

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Responsible Party: Thomas Tängdén, Associate professor, Uppsala University
ClinicalTrials.gov Identifier: NCT04001309     History of Changes
Other Study ID Numbers: Dnr 2018-423
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Tängdén, Uppsala University:
antimicrobial stewardship
prospective audit and feedback
infectious diseases
randomized trial

Additional relevant MeSH terms:
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Communicable Diseases
Infection
Anti-Infective Agents
Anti-Bacterial Agents