Antibiotics for Delirium in Older Adults

This study is looking at whether antibiotics can help older adults who have delirium (a sudden state of confusion) and bacteria in their urine, but no clear urinary tract infection (UTI). Many older adults in the hospital get delirium, and while bacteria in the urine is common, it doesn't always mean there's an infection. It's hard to tell if a UTI is causing delirium because confused patients often can't describe symptoms. This study will compare giving antibiotics to not giving antibiotics to see if it improves delirium by day 7 or when you leave the hospital. You might be able to join if you are 60 or older, in the hospital with delirium, and have had less than 24 hours of antibiotics.

Study design: This study is an interventional study planning to enroll 550 participants. Participants will be randomly assigned to either receive antibiotics or no antibiotics.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Delirium will be assessed at the first of day 7 or discharge from the hospital.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

NAAges 60+InterventionalTreatment

Mount Sinai Hospital, Canada

~550 participants

Updated 2024-09-19 on ClinicalTrials.gov

What's tested:Start Antibiotics / Continue Antibiotics for treatment of bacteriuriaNo Antibiotics for treatment of bacteriuria

At a glance

Recruiting sites

2 of 7 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Delirium at day 7 or at day of hospital discharge, whichever is earliest

Measured over Delirium will be assessed at the first of day 7 or discharge

Conditions

Infectious Disease

Where it's being run

7 sites across 2 states

Canada6

Illinois1

Study leadership

Michael Fralick, MD, PhD · PRINCIPAL_INVESTIGATOR · Sinai Health System
Chris Kandel, MD, PhD · PRINCIPAL_INVESTIGATOR · Michael Garron Hospital
Nathan Stall, MD, PhD · PRINCIPAL_INVESTIGATOR · Sinai Health System

Who to contact

Michael Fralick, MD

[email protected]

(416) 586-4800

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

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

Trialytics