<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03256825</url>
  </required_header>
  <id_info>
    <org_study_id>RUDE/01-2016</org_study_id>
    <nct_id>NCT03256825</nct_id>
  </id_info>
  <brief_title>Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support</brief_title>
  <acronym>RUDE</acronym>
  <official_title>Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support - Accuracy and Effect on Antibiotic Consumption</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Helse Møre og Romsdal HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Helse Møre og Romsdal HF</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to assess the accuracy and impact of rapid diagnosis and rapid diagnosis&#xD;
      decision support on different aspects of antibiotic consumption when implemented alone or&#xD;
      together.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This interventional study in two centers compares two groups with each other and with a&#xD;
      pre-intervention control group. In group 1 rapid techniques for handling urine cultures will&#xD;
      be the only intervention. In group 2 rapid diagnostics will be supplemented with real-time&#xD;
      antimicrobial stewardship decision support (RADS). In each center two departments will be&#xD;
      involved.&#xD;
&#xD;
      Urine samples present at the laboratory at opening on weekdays will be screened using urine&#xD;
      flow cytometry and microscopy of centrifuged gram stained urine. Samples found positive for&#xD;
      significant mono microbial bacteriuria will be investigated further by using direct automated&#xD;
      phenotypic identification and antimicrobial susceptibility determination and screened for&#xD;
      inclusion in the interventional study.&#xD;
&#xD;
      In one of the centers, rapid techniques will be coupled to real-time antimicrobial&#xD;
      stewardship decision support (RADS). RADS will be given by telephone to a designated&#xD;
      clinician with the aim of:&#xD;
&#xD;
        1. Switch to active treatment if non-working empirical treatment&#xD;
&#xD;
        2. De-escalate broad spectrum empiric treatment when feasible&#xD;
&#xD;
        3. Promote early intravenous to per oral switch&#xD;
&#xD;
        4. Shorten treatment duration&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause 30-day mortality</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence to guidelines for empirical therapy</measure>
    <time_frame>Recorded at inclusion or within 30 days after admission/inclusion.</time_frame>
    <description>Antibiotics given before results of microbiology diagnostics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total antibiotic consumption in intervention groups and control group compared</measure>
    <time_frame>Recorded at inclusion or within 30 days after admission/inclusion.</time_frame>
    <description>Total consumption of antibiotic during admission and prescribed oral antibiotics after discharge. Expressed in (DDD) &quot;the assumed average maintenance dose per day for the drug used for its main indication in adults&quot; / admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group.</measure>
    <time_frame>Recorded 30 days after admission/inclusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from admission to optimal antibiotic therapy</measure>
    <time_frame>Recorded 30 days after admission/inclusion.</time_frame>
    <description>Optimal treatment is defined as the working treatment with the most narrow spectrum possible</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment</measure>
    <time_frame>Recorded within 30 days after admission/inclusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment duration - intravenous/per oral</measure>
    <time_frame>Recorded within 30 days after admission/inclusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit length of stay</measure>
    <time_frame>Recorded within 30 days after admission/inclusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Recorded within 30 days after admission/inclusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of adherence to treatment suggestions given as RADS</measure>
    <time_frame>Recorded within 30 days after admission/inclusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of readmission for urinary tract infection within 30 days of discharge</measure>
    <time_frame>Recorded within 30 days after admission/inclusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Turnaround time of rapid diagnostic procedures compared to conventional diagnostics</measure>
    <time_frame>Recorded within 30 days after admission/inclusion.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of rapid diagnostic procedures compared to conventional diagnostics</measure>
    <time_frame>Recorded within 30 days after admission/inclusion.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Urinary Tract Infections</condition>
  <arm_group>
    <arm_group_label>Rapid diagnostics</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rapid diagnostics and RADS</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Rapid diagnostics alone</intervention_name>
    <description>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.</description>
    <arm_group_label>Rapid diagnostics</arm_group_label>
    <arm_group_label>Rapid diagnostics and RADS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Real-time antimicrobial stewardship decision support</intervention_name>
    <description>A clinical microbiologist will be give RADS by phone to a designated clinician with the aim of:&#xD;
Switch to active treatment if non-working empirical treatment&#xD;
De-escalate broad spectrum empiric treatment when feasible&#xD;
Promote early intravenous to per oral switch&#xD;
Shorten treatment duration</description>
    <arm_group_label>Rapid diagnostics and RADS</arm_group_label>
    <other_name>RADS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Urine sample present at the laboratory weekdays&#xD;
&#xD;
          -  At least 11 ml of urine in sample&#xD;
&#xD;
          -  Admitted to surgical or medical ward.&#xD;
&#xD;
          -  Urine sample taken on admission to hospital.&#xD;
&#xD;
          -  Rapid diagnostics suggesting mono microbial growth of &gt; 100.000 microbes/ml urine.&#xD;
&#xD;
          -  Clinical and laboratory signs/symptoms of urinary tract infection at time of sample&#xD;
             delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other simultaneous infections that warrant systemic antimicrobial therapy or surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Einar Nilsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Møre and Romsdal Health Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Molde Hospital</name>
      <address>
        <city>Molde</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ålesund Hospital</name>
      <address>
        <city>Ålesund</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>22831285</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>May 11, 2020</last_update_submitted>
  <last_update_submitted_qc>May 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diagnostic accuracy</keyword>
  <keyword>Anti-bacterial agents</keyword>
  <keyword>Decision support systems, clinical</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Infective Agents</mesh_term>
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD will be shared with other investigators.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03256825
org study id: RUDE/01-2016
nct id: NCT03256825
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: All-cause 30-day mortality
time frame: 30 days
measure: Adherence to guidelines for empirical therapy
time frame: Recorded at inclusion or within 30 days after admission/inclusion.
description: Antibiotics given before results of microbiology diagnostics.
measure: Total antibiotic consumption in intervention groups and control group compared
time frame: Recorded at inclusion or within 30 days after admission/inclusion.
description: 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
measure: Use of broad spectrum antibiotics - DDD/admission in intervention groups compared with control group.
time frame: Recorded 30 days after admission/inclusion.
measure: Time from admission to optimal antibiotic therapy
time frame: Recorded 30 days after admission/inclusion.
description: Optimal treatment is defined as the working treatment with the most narrow spectrum possible
measure: Frequency of errors by rapid diagnostics/errors in RADS leading to non-working treatment
time frame: Recorded within 30 days after admission/inclusion.
measure: Treatment duration - intravenous/per oral
time frame: Recorded within 30 days after admission/inclusion.
measure: Intensive care unit length of stay
time frame: Recorded within 30 days after admission/inclusion.
measure: Hospital length of stay
time frame: Recorded within 30 days after admission/inclusion.
measure: Frequency of adherence to treatment suggestions given as RADS
time frame: Recorded within 30 days after admission/inclusion.
measure: Frequency of readmission for urinary tract infection within 30 days of discharge
time frame: Recorded within 30 days after admission/inclusion.
measure: Turnaround time of rapid diagnostic procedures compared to conventional diagnostics
time frame: Recorded within 30 days after admission/inclusion.
measure: Accuracy of rapid diagnostic procedures compared to conventional diagnostics
time frame: Recorded within 30 days after admission/inclusion.
arm group label: Rapid diagnostics
arm group type: Other
description: 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.
arm group label: Rapid diagnostics and RADS
arm group type: Other
description: 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.
intervention type: Diagnostic Test
intervention name: Rapid diagnostics alone
description: 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.
arm group label: Rapid diagnostics
arm group label: Rapid diagnostics and RADS
intervention type: Other
intervention name: Real-time antimicrobial stewardship decision support
description: 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
arm group label: Rapid diagnostics and RADS
other name: RADS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Einar Nilsen, MD
role: Principal Investigator
affiliation: Møre and Romsdal Health Trust
facility: 
facility: 
country: Norway
citation: 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
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
mesh term: Anti-Infective Agents
mesh term: Anti-Bacterial Agents
sharing ipd: No
ipd description: No IPD will be shared with other investigators.