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NCT Number: NCT06004739

Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection

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.

Recruiting

Interested in participating?

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Key information

Who can participate

Healthy volunteers accepted: No

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

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 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
  • Receipt of an antibiotic where a single dose suffices for the treatment of a UTI (such as Fosfomycin)

Treatment and study plan

Start Antibiotics / Continue Antibiotics for treatment of bacteriuria

Drug

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 for treatment of bacteriuria

Other

Participants will be randomized to no antibiotics

Primary outcomes

  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). 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].

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Fralick, MD

CONTACT

[email protected]

(416) 586-4800

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

  • Michael Garron Hospital
  • Northwestern Memorial Hospital
  • Sault Area Hospital
  • The Ottawa Hospital
  • Unity Health Toronto

Registry information

Acronym: A-DONUT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2023
Registry last updated
Sep 19, 2024

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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