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

Urinary Tract Infections Clinical Trial

— RUDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256825
• Other study ID #: RUDE/01-2016
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: May 2020
• Source: Helse Møre og Romsdal HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
Norway	Ålesund Hospital	Ålesund
Norway	Molde Hospital	Molde

Sponsors (1)

Lead Sponsor	Collaborator
Helse Møre og Romsdal HF

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause 30-day mortality		30 days
Secondary	Adherence to guidelines for empirical therapy	Antibiotics given before results of microbiology diagnostics.	Recorded at inclusion or within 30 days after admission/inclusion.
Secondary	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.
Secondary	Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group.		Recorded 30 days after admission/inclusion.
Secondary	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.
Secondary	Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment		Recorded within 30 days after admission/inclusion.
Secondary	Treatment duration - intravenous/per oral		Recorded within 30 days after admission/inclusion.
Secondary	Intensive care unit length of stay		Recorded within 30 days after admission/inclusion.
Secondary	Hospital length of stay		Recorded within 30 days after admission/inclusion.
Secondary	Frequency of adherence to treatment suggestions given as RADS		Recorded within 30 days after admission/inclusion.
Secondary	Frequency of readmission for urinary tract infection within 30 days of discharge		Recorded within 30 days after admission/inclusion.
Secondary	Turnaround time of rapid diagnostic procedures compared to conventional diagnostics		Recorded within 30 days after admission/inclusion.
Secondary	Accuracy of rapid diagnostic procedures compared to conventional diagnostics		Recorded within 30 days after admission/inclusion.