- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04798365
Antimicrobial Stewardship in UTIs in Nursing Homes
Implementation of an Antimicrobial Stewardship Program Targeting Residents With Urinary Tract Infections in Long-term Care Facilities
Background: The widespread inappropriate use of antimicrobial substances drives resistance development at the individual and population level all over the world. In long-term care facilities (LTCF), antibiotics are among the most frequently prescribed medications. More than one third of antibiotics prescribed in LTCFs are for urinary tract infections (UTI). Studies have shown that 30 - 40% of antibiotic courses prescribed in LTCFs were unnecessary and that more than two-thirds were inappropriate based on society guidelines.
Preliminary data: A surveillance study on healthcare-associated UTIs at LTCFs of the Geriatric Health Centers Graz revealed that guideline recommendations on antimicrobial choice were met in only 50% of patients. The most frequently used antimicrobial substances for UTI were quinolones.
Aims: Using a multifaceted bundle of antimicrobial stewardship interventions consisting of clinical practice guidelines, care pathways and local as well as web-based education and training targeting nursing staff as well as physicians we aim to improve the quality of antimicrobial prescriptions for UTIs in four LTCFs in Graz, Austria.
Design: Non-randomized cluster controlled intervention study. Setting: The Geriatric Health Centers Graz are a local institution comprising among others 4 LTCFs (total of 400 beds). These will serve as intervention group. Four LTCFs located in the surroundings of Graz will serve as control group.
Intervention: The main components of the intervention are 1) two sessions of voluntary continuing medical education on the urinary tract infection program in each LTCF for physicians and nursing staff, 2) distribution of educations materials such as written guidelines on antibiotic prescribing including a smart phone friendly version, 3) implementation of the project homepage as a platform to distribute guidelines and educational videos and to enable physicians to ask questions which will be answered by an infectious disease physician.
Outcomes: The primary outcome will be the proportion of adequate prescriptions (adequate in terms of antimicrobial choice). Secondary outcomes include proportion of adequate prescriptions (adequate in terms of decision to treat), number of cases with clinical failure, number of admissions to hospital due to UTI, number of adverse events attributed to antimicrobial treatment for UTI, percentage of extended spectrum betalactamase (ESBL) producing enterobacteria isolated from urinary cultures
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Fehring, Austria, 8350
- Sonnenhof
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Graz, Austria, 8010
- Geriatric Health Centres of the City of Graz
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Graz, Austria, 8010
- Volkshilfe Steiermark
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Voitsberg, Austria, 8570
- Bezirkspflege-und Seniorenheim Voitsberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- residents living in the participating long term care facilities who experience urinary tract infections (UTI)
Exclusion Criteria:
- residents without UTI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
The main components of the intervention are 1) two sessions of voluntary continuing medical education on the urinary tract infection program in each LTCF for physicians and nursing staff, 2) distribution of educations materials such as written guidelines on antibiotic prescribing including a smart phone friendly version, 3) implementation of the project homepage as a platform to distribute guidelines and educational videos and to enable physicians to ask questions which will be answered by an infectious disease physician.
|
medical education and distribution of educations materials
|
|
No Intervention: Control group
No intervention until end of the stuy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
proportion of adequate prescriptions (adequate in terms of antimicrobial choice)
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33-035 ex 20/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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