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

Overview

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.

Full Title of Study: “Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support – Accuracy and Effect on Antibiotic Consumption”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 1, 2019

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

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • All-cause 30-day mortality
    • Time Frame: 30 days

Secondary Measures

  • Adherence to guidelines for empirical therapy
    • Time Frame: 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
    • Time Frame: 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.
    • Time Frame: Recorded 30 days after admission/inclusion.
  • Time from admission to optimal antibiotic therapy
    • Time Frame: 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
    • Time Frame: Recorded within 30 days after admission/inclusion.
  • Treatment duration – intravenous/per oral
    • Time Frame: Recorded within 30 days after admission/inclusion.
  • Intensive care unit length of stay
    • Time Frame: Recorded within 30 days after admission/inclusion.
  • Hospital length of stay
    • Time Frame: Recorded within 30 days after admission/inclusion.
  • Frequency of adherence to treatment suggestions given as RADS
    • Time Frame: Recorded within 30 days after admission/inclusion.
  • Frequency of readmission for urinary tract infection within 30 days of discharge
    • Time Frame: Recorded within 30 days after admission/inclusion.
  • Turnaround time of rapid diagnostic procedures compared to conventional diagnostics
    • Time Frame: Recorded within 30 days after admission/inclusion.
  • Accuracy of rapid diagnostic procedures compared to conventional diagnostics
    • Time Frame: Recorded within 30 days after admission/inclusion.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helse Møre og Romsdal HF
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Einar Nilsen, MD, Principal Investigator, Møre and Romsdal Health Trust

References

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.

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