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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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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:

1. Switch to active treatment if non-working empirical treatment
2. De-escalate broad spectrum empiric treatment when feasible
3. Promote early intravenous to per oral switch
4. Shorten treatment duration

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Rapid diagnostics

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.

Group Type OTHER

Rapid diagnostics alone

Intervention Type DIAGNOSTIC_TEST

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.

Rapid diagnostics and RADS

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.

Group Type OTHER

Rapid diagnostics alone

Intervention Type DIAGNOSTIC_TEST

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.

Real-time antimicrobial stewardship decision support

Intervention Type OTHER

A clinical microbiologist will be give RADS by phone to a designated clinician with the aim of:

1. Switch to active treatment if non-working empirical treatment
2. De-escalate broad spectrum empiric treatment when feasible
3. Promote early intravenous to per oral switch
4. Shorten treatment duration

Interventions

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Rapid diagnostics alone

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 DIAGNOSTIC_TEST

Real-time antimicrobial stewardship decision support

A clinical microbiologist will be give RADS by phone to a designated clinician with the aim of:

1. Switch to active treatment if non-working empirical treatment
2. De-escalate broad spectrum empiric treatment when feasible
3. Promote early intravenous to per oral switch
4. Shorten treatment duration

Intervention Type OTHER

Other Intervention Names

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RADS

Eligibility Criteria

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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.