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

Sponsor
Helse Møre og Romsdal HF (Other)
Overall Status
Completed
CT.gov ID
NCT03256825
Collaborator
(none)
400
2
2
26
200
7.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Rapid diagnostics alone
  • Other: Real-time antimicrobial stewardship decision support
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
400 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. All-cause 30-day mortality [30 days]

    Secondary Outcome Measures

    1. Adherence to guidelines for empirical therapy [Recorded at inclusion or within 30 days after admission/inclusion.]

      Antibiotics given before results of microbiology diagnostics.

    2. 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

    3. Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group. [Recorded 30 days after admission/inclusion.]

    4. 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

    5. Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment [Recorded within 30 days after admission/inclusion.]

    6. Treatment duration - intravenous/per oral [Recorded within 30 days after admission/inclusion.]

    7. Intensive care unit length of stay [Recorded within 30 days after admission/inclusion.]

    8. Hospital length of stay [Recorded within 30 days after admission/inclusion.]

    9. Frequency of adherence to treatment suggestions given as RADS [Recorded within 30 days after admission/inclusion.]

    10. Frequency of readmission for urinary tract infection within 30 days of discharge [Recorded within 30 days after admission/inclusion.]

    11. Turnaround time of rapid diagnostic procedures compared to conventional diagnostics [Recorded within 30 days after admission/inclusion.]

    12. Accuracy of rapid diagnostic procedures compared to conventional diagnostics [Recorded within 30 days after admission/inclusion.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Molde Hospital Molde Norway
    2 Ålesund Hospital Ålesund Norway

    Sponsors and Collaborators

    • Helse Møre og Romsdal HF

    Investigators

    • Principal Investigator: Einar Nilsen, MD, Møre and Romsdal Health Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Helse Møre og Romsdal HF
    ClinicalTrials.gov Identifier:
    NCT03256825
    Other Study ID Numbers:
    • RUDE/01-2016
    First Posted:
    Aug 22, 2017
    Last Update Posted:
    May 12, 2020
    Last Verified:
    May 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Helse Møre og Romsdal HF
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 12, 2020