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Recruiting NCT06004739

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

No phase Interventional Infectious Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Start Antibiotics / Continue Antibiotics for treatment of bacteriuria, No Antibiotics for treatment of bacteriuria.
Who it may be relevant to
Registry conditions: Infectious Disease. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • Other No Antibiotics for treatment of bacteriuria
    Participants will be randomized to no antibiotics

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Length of hospitalization [Time frame: Up to 30 days]
  • Number of participants with bacteremia (bacteria isolated in blood culture) [Time frame: Up to 7 days]
  • Number of participants who were transferred to Intensive Care Unit (ICU) [Time frame: Up to 7 days]
  • Number of participants who had a fall [Time frame: Up to 7 days]
  • Number of participants who were physically restrained [Time frame: Up to 7 days]
  • Number of participants who received antipsychotics [Time frame: Up to 7 days]
  • Days of antibiotics [Time frame: Up to 7 days]
  • Number of participants with C. difficile infection [Time frame: By 30 days]
  • Number of participants who died [Time frame: By 30 days]
  • Number of participants who died [Time frame: By 365 days]
  • Number of participants who were readmitted to hospital [Time frame: By 365 days]
  • Number of participants who were readmitted to hospital [Time frame: By 30 days]

Eligibility 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 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 6 centers
  • The Ottawa Hospital Civic Campus — Ottawa
  • The Ottawa Hospital General Campus — Ottawa
  • Hennick Bridgepoint Hospital — Toronto
  • Michael Garron Hospital — Toronto
  • Mount Sinai Hospital — Toronto
  • Toronto General Hospital — Toronto
United States · 1 center
  • Northwestern Memorial Hospital — Chicago

Identifiers

NCT: NCT06004739 · CTO 4466

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗