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Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection (A-DONUT)

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ClinicalTrials.gov Identifier: NCT06004739
Recruitment Status : Recruiting
First Posted : August 22, 2023
Last Update Posted : April 25, 2024
Sponsor:
Collaborators:
Sault Area Hospital
Michael Garron Hospital
Unity Health Toronto
The Ottawa Hospital
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infectious Disease Drug: Start Antibiotics / Continue Antibiotics for treatment of bacteriuria Other: No Antibiotics for treatment of bacteriuria Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection
Estimated Study Start Date : April 2024
Estimated Primary Completion Date : September 2027
Estimated Study Completion Date : September 2027

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Arms and Interventions
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Arm Intervention/treatment
Antibiotics
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).
 Drug: Start Antibiotics / Continue Antibiotics for treatment of bacteriuria
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.
No Antibiotics
Participants will be randomized to no antibiotics
 Other: No Antibiotics for treatment of bacteriuria
Participants will be randomized to no antibiotics


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Length of hospitalization [ Time Frame: Up to 30 days ]
  2. Number of participants with bacteremia (bacteria isolated in blood culture) [ Time Frame: Up to 7 days ]
  3. Number of participants who were transferred to Intensive Care Unit (ICU) [ Time Frame: Up to 7 days ]
  4. Number of participants who had a fall [ Time Frame: Up to 7 days ]
  5. Number of participants who were physically restrained [ Time Frame: Up to 7 days ]
  6. Number of participants who received antipsychotics [ Time Frame: Up to 7 days ]
  7. Days of antibiotics [ Time Frame: Up to 7 days ]
  8. Number of participants with C. difficile infection [ Time Frame: By 30 days ]
    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)

  9. Number of participants who died [ Time Frame: By 30 days ]
  10. Number of participants who died [ Time Frame: By 365 days ]
  11. Number of participants who were readmitted to hospital [ Time Frame: By 365 days ]
  12. Number of participants who were readmitted to hospital [ Time Frame: By 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Age ≥ 60 and admitted to a hospital ward (including rehabilitation hospital);
  • Active delirium (defined by CAM: [1] inattention AND [2] acute and fluctuating level of consciousness, and either [3] disorganized thinking OR [4] altered mental status; or defined by the 4AT score [www.the4at.com/]) OR physician's diagnosis
  • Less than 24 hours of antibiotics (prior to trial assessment)
  • Either pyuria (defined as white blood cells detected on urinalysis or dipstick) or bacteriuria (defined as bacteria growing on urine culture)

Exclusion criteria

  • Fever (temperature > 37.9C or > 100.2F) in the past 48 hours;
  • Signs of lower urinary tract infection symptoms (such as new dysuria) or upper urinary symptoms (such as costovertebral tenderness)
  • In the opinion of the treating physician, there is a reason apart from delirium and urine test results to treat with antibiotics (e.g., pneumonia)
  • Indwelling urinary catheter for > 72 hours
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06004739


Contacts
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Contact: Michael Fralick, MD (416) 586-4800 mike.fralick@mail.utoronto.ca

Locations
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Canada, Ontario
Sault Area Hospital Recruiting
Sault Ste. Marie, Ontario, Canada
Contact: Lucas Castellani         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Sault Area Hospital
Michael Garron Hospital
Unity Health Toronto
The Ottawa Hospital
Investigators
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Principal Investigator: Michael Fralick, MD, PhD Sinai Health System
Principal Investigator: Chris Kandel, MD, PhD Michael Garron Hospital
More Information
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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT06004739    
Other Study ID Numbers: CTO 4466
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: April 25, 2024
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mount Sinai Hospital, Canada:
Delirium
Antibiotics
Older adults
Urinary Tract Infection
Additional relevant MeSH terms:
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Infections
Urinary Tract Infections
Communicable Diseases
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents