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

NCT06004739 · tracked via the Priya Life Science Canada tracker

Sponsor

Mount Sinai Hospital, Canada

Phase

Not applicable

Started

2024-05-18

Last updated

2024-09-19

Condition(s) studied

Infectious Disease

Investigational drug(s) / intervention(s)

Start Antibiotics / Continue Antibiotics for treatment of bacteriuriaNo Antibiotics for treatment of bacteriuria

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 for treatment of bacteriuria: Participants will be randomized to no antibiotics

Study 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.

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Delirium at day 7 or at day of hospital discharge, whichever is earliest — 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 \[4\].

Trial sites (7)

Facility	City	Region	Status
Northwestern Memorial Hospital	Chicago	Illinois	Not Yet Recruiting
The Ottawa Hospital Civic Campus	Ottawa	Canada	Not Yet Recruiting
The Ottawa Hospital General Campus	Ottawa	Canada	Not Yet Recruiting
Hennick Bridgepoint Hospital	Toronto	Canada	Not Yet Recruiting
Michael Garron Hospital	Toronto	Canada	Recruiting
Mount Sinai Hospital	Toronto	Canada	Recruiting
Toronto General Hospital	Toronto	Canada	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06004739 on ClinicalTrials.gov ↗ ← All trials in Canada