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

Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Diagnostic test: Rapid diagnostics alone; Other: Real-time antimicrobial stewardship decision support

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

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Molde, Norway
    • Molde Hospital
  • Ålesund, Norway
    • Ålesund Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Diagnostic test: 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.
Other: 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.	Diagnostic test: 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.; Other: Real-time antimicrobial stewardship decision support; 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; Other Names: RADS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause 30-day mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to guidelines for empirical therapy	Antibiotics given before results of microbiology diagnostics.	Recorded at inclusion or within 30 days after admission/inclusion.
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	Recorded at inclusion or within 30 days after admission/inclusion.
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	Optimal treatment is defined as the working treatment with the most narrow spectrum possible	Recorded 30 days after admission/inclusion.
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.

Collaborators and Investigators

• Sponsor: Helse Møre og Romsdal HF
• Investigators: Principal Investigator: Einar Nilsen, MD, Møre and Romsdal Health Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Diagnostic accuracy; Anti-bacterial agents; Decision support systems, clinical
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: RUDE/01-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No