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Completed

NCT Number: NCT03256825

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Molde Hospital, Molde, Norway

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About this study

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:

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Real-time antimicrobial stewardship decision support

Other

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

Primary outcomes

  1. All-cause 30-day mortality

    Time frame: 30 days

Secondary outcomes

  1. 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.

  2. 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

  3. Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group.

    Time frame: Recorded 30 days after admission/inclusion.

  4. 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

  5. Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment

    Time frame: Recorded within 30 days after admission/inclusion.

  6. Treatment duration - intravenous/per oral

    Time frame: Recorded within 30 days after admission/inclusion.

  7. Intensive care unit length of stay

    Time frame: Recorded within 30 days after admission/inclusion.

  8. Hospital length of stay

    Time frame: Recorded within 30 days after admission/inclusion.

  9. Frequency of adherence to treatment suggestions given as RADS

    Time frame: Recorded within 30 days after admission/inclusion.

  10. Frequency of readmission for urinary tract infection within 30 days of discharge

    Time frame: Recorded within 30 days after admission/inclusion.

  11. Turnaround time of rapid diagnostic procedures compared to conventional diagnostics

    Time frame: Recorded within 30 days after admission/inclusion.

  12. Accuracy of rapid diagnostic procedures compared to conventional diagnostics

    Time frame: Recorded within 30 days after admission/inclusion.

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Registry information

Official study title

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

Acronym: RUDE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2017
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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