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

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Diagnostic Test: Rapid diagnostics alone; Other: Real-time antimicrobial stewardship decision support

• Registration Number: NCT03256825
• Lead Sponsor: Helse Møre og Romsdal HF

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:

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-22
• Study Start: 2017-09-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Rapid diagnostics and RADS	Real-time antimicrobial stewardship decision support	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.
Rapid diagnostics	Rapid diagnostics alone	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.
Rapid diagnostics and RADS	Rapid diagnostics alone	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.

Primary Outcome Measures

Name	Time	Method
All-cause 30-day mortality	30 days

Secondary Outcome Measures

Name	Time	Method
Adherence to guidelines for empirical therapy	Recorded at inclusion or within 30 days after admission/inclusion.	Antibiotics given before results of microbiology diagnostics.
Total antibiotic consumption in intervention groups and control group compared	Recorded at inclusion or within 30 days after admission/inclusion.	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.	Recorded 30 days after admission/inclusion.
Time from admission to optimal antibiotic therapy	Recorded 30 days after admission/inclusion.	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	Recorded within 30 days after admission/inclusion.
Treatment duration - intravenous/per oral	Recorded within 30 days after admission/inclusion.
Intensive care unit length of stay	Recorded within 30 days after admission/inclusion.
Hospital length of stay	Recorded within 30 days after admission/inclusion.
Frequency of adherence to treatment suggestions given as RADS	Recorded within 30 days after admission/inclusion.
Frequency of readmission for urinary tract infection within 30 days of discharge	Recorded within 30 days after admission/inclusion.
Turnaround time of rapid diagnostic procedures compared to conventional diagnostics	Recorded within 30 days after admission/inclusion.
Accuracy of rapid diagnostic procedures compared to conventional diagnostics	Recorded within 30 days after admission/inclusion.

Trial Locations

Locations (2)

Molde Hospital; 🇳🇴 Molde, Norway

Ålesund Hospital; 🇳🇴 Ålesund, Norway