Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
NCT06004739

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

Led by Mount Sinai Hospital, Canada · Updated on 2024-09-19

550

Participants Needed

7

Research Sites

171 weeks

Total Duration

On this page

Sponsors

M

Mount Sinai Hospital, Canada

Lead Sponsor

S

Sault Area Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older and admitted to a hospital ward, including rehabilitation hospital
  • Active delirium defined by specific clinical criteria or physician's diagnosis
  • Less than 24 hours of antibiotics use before trial assessment
  • Presence of pyuria (white blood cells in urine) or bacteriuria (bacteria in urine culture)
Not Eligible

You will not qualify if you...

  • Fever over 37.9°C (100.2°F) in the past 48 hours
  • Symptoms of lower urinary tract infection or upper urinary symptoms
  • Physician believes antibiotics are needed for reasons other than delirium and urine test results
  • Indwelling urinary catheter in place for more than 72 hours
  • Received a single-dose antibiotic that suffices for urinary tract infection treatment (e.g., Fosfomycin)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Not Yet Recruiting

2

The Ottawa Hospital Civic Campus

Ottawa, Canada

Not Yet Recruiting

3

The Ottawa Hospital General Campus

Ottawa, Canada

Not Yet Recruiting

4

Hennick Bridgepoint Hospital

Toronto, Canada

Not Yet Recruiting

5

Michael Garron Hospital

Toronto, Canada

Actively Recruiting

6

Mount Sinai Hospital

Toronto, Canada

Actively Recruiting

7

Toronto General Hospital

Toronto, Canada

Not Yet Recruiting

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Research Team

M

Michael Fralick, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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