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Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support (RUDE)

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Rapid diagnostics alone
Real-time antimicrobial stewardship decision support
Sponsored by
Helse Møre og Romsdal HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Tract Infections focused on measuring Diagnostic accuracy, Anti-bacterial agents, Decision support systems, clinical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Urine sample present at the laboratory weekdays
  • At least 11 ml of urine in sample
  • Admitted to surgical or medical ward.
  • Urine sample taken on admission to hospital.
  • Rapid diagnostics suggesting mono microbial growth of > 100.000 microbes/ml urine.
  • Clinical and laboratory signs/symptoms of urinary tract infection at time of sample delivery.

Exclusion Criteria:

  • Other simultaneous infections that warrant systemic antimicrobial therapy or surgery.

Sites / Locations

  • Molde Hospital
  • Ålesund Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Rapid diagnostics

Rapid diagnostics and RADS

Arm Description

patients admitted to medical and surgical wards with urinary tract infections at Ålesund Hospital, Moere and Romsdal, Norway. Here, rapid diagnostics alone will be implemented.

patients admitted to medical and surgical wards with urinary tract infections at Molde Hospital, Moere and Romsdal, Norway. Here, rapid diagnostics will be implemented in conjunction with Real-time antimicrobial stewardship decision support : rapid diagnostics and RADS.

Outcomes

Primary Outcome Measures

All-cause 30-day mortality

Secondary Outcome Measures

Adherence to guidelines for empirical therapy
Antibiotics given before results of microbiology diagnostics.
Total antibiotic consumption in intervention groups and control group compared
Total consumption of antibiotic during admission and prescribed oral antibiotics after discharge. Expressed in (DDD) "the assumed average maintenance dose per day for the drug used for its main indication in adults" / admission
Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group.
Time from admission to optimal antibiotic therapy
Optimal treatment is defined as the working treatment with the most narrow spectrum possible
Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment
Treatment duration - intravenous/per oral
Intensive care unit length of stay
Hospital length of stay
Frequency of adherence to treatment suggestions given as RADS
Frequency of readmission for urinary tract infection within 30 days of discharge
Turnaround time of rapid diagnostic procedures compared to conventional diagnostics
Accuracy of rapid diagnostic procedures compared to conventional diagnostics

Full Information

First Posted
August 15, 2017
Last Updated
May 11, 2020
Sponsor
Helse Møre og Romsdal HF
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1. Study Identification

Unique Protocol Identification Number
NCT03256825
Brief Title
Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support
Acronym
RUDE
Official Title
Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Møre og Romsdal HF

4. Oversight

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

5. Study Description

Brief Summary
The study aims to assess the accuracy and impact of rapid diagnosis and rapid diagnosis decision support on different aspects of antibiotic consumption when implemented alone or together.
Detailed Description
This interventional study in two centers compares two groups with each other and with a pre-intervention control group. In group 1 rapid techniques for handling urine cultures will be the only intervention. In group 2 rapid diagnostics will be supplemented with real-time antimicrobial stewardship decision support (RADS). In each center two departments will be involved. Urine samples present at the laboratory at opening on weekdays will be screened using urine flow cytometry and microscopy of centrifuged gram stained urine. Samples found positive for significant mono microbial bacteriuria will be investigated further by using direct automated phenotypic identification and antimicrobial susceptibility determination and screened for inclusion in the interventional study. In one of the centers, rapid techniques will be coupled to real-time antimicrobial stewardship decision support (RADS). RADS will be given by telephone to a designated clinician with the aim of: Switch to active treatment if non-working empirical treatment De-escalate broad spectrum empiric treatment when feasible Promote early intravenous to per oral switch Shorten treatment duration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Diagnostic accuracy, Anti-bacterial agents, Decision support systems, clinical

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid diagnostics
Arm Type
Other
Arm Description
patients admitted to medical and surgical wards with urinary tract infections at Ålesund Hospital, Moere and Romsdal, Norway. Here, rapid diagnostics alone will be implemented.
Arm Title
Rapid diagnostics and RADS
Arm Type
Other
Arm Description
patients admitted to medical and surgical wards with urinary tract infections at Molde Hospital, Moere and Romsdal, Norway. Here, rapid diagnostics will be implemented in conjunction with Real-time antimicrobial stewardship decision support : rapid diagnostics and RADS.
Intervention Type
Diagnostic Test
Intervention Name(s)
Rapid diagnostics alone
Intervention Description
Urine samples present at the laboratory at opening on weekdays will be screened using urine flow cytometry and microscopy of centrifuged gram stained urine. Samples found positive for significant mono microbial bacteriuria will be investigated further by using direct automated phenotypic identification and antimicrobial susceptibility determination.
Intervention Type
Other
Intervention Name(s)
Real-time antimicrobial stewardship decision support
Other Intervention Name(s)
RADS
Intervention Description
A clinical microbiologist will be give RADS by phone to a designated clinician with the aim of: Switch to active treatment if non-working empirical treatment De-escalate broad spectrum empiric treatment when feasible Promote early intravenous to per oral switch Shorten treatment duration
Primary Outcome Measure Information:
Title
All-cause 30-day mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Adherence to guidelines for empirical therapy
Description
Antibiotics given before results of microbiology diagnostics.
Time Frame
Recorded at inclusion or within 30 days after admission/inclusion.
Title
Total antibiotic consumption in intervention groups and control group compared
Description
Total consumption of antibiotic during admission and prescribed oral antibiotics after discharge. Expressed in (DDD) "the assumed average maintenance dose per day for the drug used for its main indication in adults" / admission
Time Frame
Recorded at inclusion or within 30 days after admission/inclusion.
Title
Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group.
Time Frame
Recorded 30 days after admission/inclusion.
Title
Time from admission to optimal antibiotic therapy
Description
Optimal treatment is defined as the working treatment with the most narrow spectrum possible
Time Frame
Recorded 30 days after admission/inclusion.
Title
Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment
Time Frame
Recorded within 30 days after admission/inclusion.
Title
Treatment duration - intravenous/per oral
Time Frame
Recorded within 30 days after admission/inclusion.
Title
Intensive care unit length of stay
Time Frame
Recorded within 30 days after admission/inclusion.
Title
Hospital length of stay
Time Frame
Recorded within 30 days after admission/inclusion.
Title
Frequency of adherence to treatment suggestions given as RADS
Time Frame
Recorded within 30 days after admission/inclusion.
Title
Frequency of readmission for urinary tract infection within 30 days of discharge
Time Frame
Recorded within 30 days after admission/inclusion.
Title
Turnaround time of rapid diagnostic procedures compared to conventional diagnostics
Time Frame
Recorded within 30 days after admission/inclusion.
Title
Accuracy of rapid diagnostic procedures compared to conventional diagnostics
Time Frame
Recorded within 30 days after admission/inclusion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Urine sample present at the laboratory weekdays At least 11 ml of urine in sample Admitted to surgical or medical ward. Urine sample taken on admission to hospital. Rapid diagnostics suggesting mono microbial growth of > 100.000 microbes/ml urine. Clinical and laboratory signs/symptoms of urinary tract infection at time of sample delivery. Exclusion Criteria: Other simultaneous infections that warrant systemic antimicrobial therapy or surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einar Nilsen, MD
Organizational Affiliation
Møre and Romsdal Health Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Molde Hospital
City
Molde
Country
Norway
Facility Name
Ålesund Hospital
City
Ålesund
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared with other investigators.
Citations:
PubMed Identifier
22831285
Citation
Nilsen E. Automated identification and susceptibility determination directly from blood cultures facilitates early targeted antibiotic therapy. Scand J Infect Dis. 2012 Nov;44(11):860-5. doi: 10.3109/00365548.2012.689848. Epub 2012 Jul 25.
Results Reference
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Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support

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