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

NCT03256825 | Completed

• 1 other identifier: RUDE/01-2016
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Urinary Tract Infections

Keywords

Diagnostic accuracy; Anti-bacterial agents; Decision support systems, clinical

Outcome Measures

Primary Outcomes (1)

• All-cause 30-day mortality

  30 days

Secondary Outcomes (12)

• Adherence to guidelines for empirical therapy

  Recorded at inclusion or within 30 days after admission/inclusion.

• Total antibiotic consumption in intervention groups and control group compared

  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

  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.

Study Arms (2)

Rapid diagnostics

OTHER

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

Rapid diagnostics and RADS

OTHER

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; Other: Real-time antimicrobial stewardship decision support

Interventions

Rapid diagnostics alone 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; Rapid diagnostics and RADS

Real-time antimicrobial stewardship decision support 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

Also known as: RADS

Rapid diagnostics and RADS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead

Study Sites (2)

Ålesund Hospital

Ålesund, Norway

Location

Molde Hospital

Molde, Norway

Location

Related 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.

  PMID: 22831285 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Rapid Diagnostic Tests

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Officials

• Einar Nilsen, MD

  Møre and Romsdal Health Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 22, 2017
• Study Start: September 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)