xml: <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/NCT06004739</url>
    </required_header>
    <id_info>
      <org_study_id>CTO 4466</org_study_id>
      <nct_id>NCT06004739</nct_id>
    </id_info>
    <brief_title>Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection</brief_title>
    <acronym>A-DONUT</acronym>
    <official_title>Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mount Sinai Hospital, Canada</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Sault Area Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Michael Garron Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Unity Health Toronto</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Ottawa Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Mount Sinai Hospital, Canada</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Delirium is an acute confusional state that is experienced by many older adults who are&#xD;
        admitted to hospital. To treat delirium the underlying cause needs to be identified promptly,&#xD;
        but this is challenging. One of the potential causes of delirium is infection. Urine tests&#xD;
        show that most patients experiencing delirium have bacteria in their urine, however, bacteria&#xD;
        in the urine is common among older adults, and does not automatically indicate an infection&#xD;
        is present. As a result it is difficult to know whether a lower urinary tract infection is&#xD;
        present as individuals with delirium are frequently unable to report clinical signs of&#xD;
        infection - symptoms of pain or discomfort with urination, having to urinate more frequently&#xD;
        or pelvic discomfort. Very often, individuals with delirium are treated with antibiotics&#xD;
        despite the fact that it is unknown whether antibiotics help to improve delirium in cases&#xD;
        where bacteria in the urine is present. This proposed study is a randomized controlled trial&#xD;
        that will examine if adults (age 60 or older) with delirium and suspected infection benefit&#xD;
        from taking antibiotics.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Delirium at day 7 or at day of hospital discharge, whichever is earliest</measure>
      <time_frame>Delirium will be assessed at the first of day 7 or discharge</time_frame>
      <description>Delirium will be assessed using Confusion Assessment Method (CAM) or 4 A's Test (4AT). CAM assesses 4 delirium features: [1] inattention, [2] acute and fluctuating level of consciousness, [3] disorganized thinking and [4] altered mental status. For a diagnosis of delirium by CAM, the patient must display feature [1] AND [2], AND EITHER [3] or [4]. The 4AT is scored from 0-12. A score of 4 or more suggests delirium.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Length of hospitalization</measure>
      <time_frame>Up to 30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with bacteremia (bacteria isolated in blood culture)</measure>
      <time_frame>Up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who were transferred to Intensive Care Unit (ICU)</measure>
      <time_frame>Up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who had a fall</measure>
      <time_frame>Up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who were physically restrained</measure>
      <time_frame>Up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who received antipsychotics</measure>
      <time_frame>Up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days of antibiotics</measure>
      <time_frame>Up to 7 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with C. difficile infection</measure>
      <time_frame>By 30 days</time_frame>
      <description>C. difficile will be defined as a combination of a positive microbiological test for C. difficile (if still hospitalized at the time of diagnosis), or self-reported diagnosis of C. difficile (provided the patient reported diarrhea and receipt of an antibiotic to treat C. difficile)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who died</measure>
      <time_frame>By 30 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who died</measure>
      <time_frame>By 365 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who were readmitted to hospital</measure>
      <time_frame>By 365 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants who were readmitted to hospital</measure>
      <time_frame>By 30 days</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">550</enrollment>
    <condition>Infectious Disease</condition>
    <arm_group>
      <arm_group_label>Antibiotics</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will be randomized to start or continue with antibiotics. Antibiotic type and duration targeted to lower urinary tract infection as directed by the Most Responsible Physician (MRP).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Antibiotics</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will be randomized to no antibiotics</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Start Antibiotics / Continue Antibiotics for treatment of bacteriuria</intervention_name>
      <description>Participants will be randomized to start or continue with antibiotics (with antibiotic duration determined by the Most Responsible Physician [MRP]). Antibiotics choice to be selected by the MRP.</description>
      <arm_group_label>Antibiotics</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No Antibiotics for treatment of bacteriuria</intervention_name>
      <description>Participants will be randomized to no antibiotics</description>
      <arm_group_label>No Antibiotics</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  Age ≥ 60 and admitted to a hospital ward (including rehabilitation hospital);&#xD;
  &#xD;
            -  Active delirium (defined by CAM: [1] inattention AND [2] acute and fluctuating level&#xD;
               of consciousness, and either [3] disorganized thinking OR [4] altered mental status;&#xD;
               or defined by the 4AT score [www.the4at.com/]) OR physician's diagnosis&#xD;
  &#xD;
            -  Less than 24 hours of antibiotics (prior to trial assessment)&#xD;
  &#xD;
            -  Either pyuria (defined as white blood cells detected on urinalysis or dipstick) or&#xD;
               bacteriuria (defined as bacteria growing on urine culture)&#xD;
  &#xD;
          Exclusion criteria&#xD;
  &#xD;
            -  Fever (temperature &gt; 37.9C or &gt; 100.2F) in the past 48 hours;&#xD;
  &#xD;
            -  Signs of lower urinary tract infection symptoms (such as new dysuria) or upper urinary&#xD;
               symptoms (such as costovertebral tenderness)&#xD;
  &#xD;
            -  In the opinion of the treating physician, there is a reason apart from delirium and&#xD;
               urine test results to treat with antibiotics (e.g., pneumonia)&#xD;
  &#xD;
            -  Indwelling urinary catheter for &gt; 72 hours&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael Fralick, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sinai Health System</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Chris Kandel, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Michael Garron Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael Fralick, MD</last_name>
      <phone>(416) 586-4800</phone>
      <email>mike.fralick@mail.utoronto.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sault Area Hospital</name>
        <address>
          <city>Sault Ste. Marie</city>
          <state>Ontario</state>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lucas Castellani</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Delirium</keyword>
    <keyword>Antibiotics</keyword>
    <keyword>Older adults</keyword>
    <keyword>Urinary Tract Infection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Urinary Tract Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Delirium</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anti-Bacterial Agents</mesh_term>
      <mesh_term>Antibiotics, Antitubercular</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004739
  org study id: CTO 4466
  nct id: NCT06004739
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Delirium is an acute confusional state that is experienced by many older adults who are
        admitted to hospital. To treat delirium the underlying cause needs to be identified promptly,
        but this is challenging. One of the potential causes of delirium is infection. Urine tests
        show that most patients experiencing delirium have bacteria in their urine, however, bacteria
        in the urine is common among older adults, and does not automatically indicate an infection
        is present. As a result it is difficult to know whether a lower urinary tract infection is
        present as individuals with delirium are frequently unable to report clinical signs of
        infection - symptoms of pain or discomfort with urination, having to urinate more frequently
        or pelvic discomfort. Very often, individuals with delirium are treated with antibiotics
        despite the fact that it is unknown whether antibiotics help to improve delirium in cases
        where bacteria in the urine is present. This proposed study is a randomized controlled trial
        that will examine if adults (age 60 or older) with delirium and suspected infection benefit
        from taking antibiotics.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Delirium at day 7 or at day of hospital discharge, whichever is earliest
  time frame: Delirium will be assessed at the first of day 7 or discharge
  description: Delirium will be assessed using Confusion Assessment Method (CAM) or 4 A's Test (4AT). CAM assesses 4 delirium features: [1] inattention, [2] acute and fluctuating level of consciousness, [3] disorganized thinking and [4] altered mental status. For a diagnosis of delirium by CAM, the patient must display feature [1] AND [2], AND EITHER [3] or [4]. The 4AT is scored from 0-12. A score of 4 or more suggests delirium.
  measure: Length of hospitalization
  time frame: Up to 30 days
  measure: Number of participants with bacteremia (bacteria isolated in blood culture)
  time frame: Up to 7 days
  measure: Number of participants who were transferred to Intensive Care Unit (ICU)
  time frame: Up to 7 days
  measure: Number of participants who had a fall
  time frame: Up to 7 days
  measure: Number of participants who were physically restrained
  time frame: Up to 7 days
  measure: Number of participants who received antipsychotics
  time frame: Up to 7 days
  measure: Days of antibiotics
  time frame: Up to 7 days
  measure: Number of participants with C. difficile infection
  time frame: By 30 days
  description: C. difficile will be defined as a combination of a positive microbiological test for C. difficile (if still hospitalized at the time of diagnosis), or self-reported diagnosis of C. difficile (provided the patient reported diarrhea and receipt of an antibiotic to treat C. difficile)
  measure: Number of participants who died
  time frame: By 30 days
  measure: Number of participants who died
  time frame: By 365 days
  measure: Number of participants who were readmitted to hospital
  time frame: By 365 days
  measure: Number of participants who were readmitted to hospital
  time frame: By 30 days
  arm group label: Antibiotics
  arm group type: Other
  description: Participants will be randomized to start or continue with antibiotics. Antibiotic type and duration targeted to lower urinary tract infection as directed by the Most Responsible Physician (MRP).
  arm group label: No Antibiotics
  arm group type: Other
  description: Participants will be randomized to no antibiotics
  intervention type: Drug
  intervention name: Start Antibiotics / Continue Antibiotics for treatment of bacteriuria
  description: Participants will be randomized to start or continue with antibiotics (with antibiotic duration determined by the Most Responsible Physician [MRP]). Antibiotics choice to be selected by the MRP.
  arm group label: Antibiotics
  intervention type: Other
  intervention name: No Antibiotics for treatment of bacteriuria
  description: Participants will be randomized to no antibiotics
  arm group label: No Antibiotics
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael Fralick, MD, PhD
  role: Principal Investigator
  affiliation: Sinai Health System
  last name: Chris Kandel, MD, PhD
  role: Principal Investigator
  affiliation: Michael Garron Hospital
  last name: Michael Fralick, MD
  phone: (416) 586-4800
  email: mike.fralick@mail.utoronto.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Urinary Tract Infections
  mesh term: Communicable Diseases
  mesh term: Delirium
  mesh term: Anti-Bacterial Agents
  mesh term: Antibiotics, Antitubercular
  sharing ipd: No