Actively Recruiting
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
N/A
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 a sudden state of confusion commonly seen in older adults admitted to hospitals, and identifying its cause quickly is important but often difficult. Infection may cause delirium, and many patients have bacteria in their urine, but bacteria alone do not always indicate a true infection. This trial studies whether antibiotics help treat delirium in adults aged 60 and older who have delirium and suspected urinary infection but no clear signs of urinary tract infection. Participants will be randomly assigned to one of two groups: one group will start or continue taking antibiotics prescribed by their main doctor, with the antibiotic type and treatment length decided by the doctor. The other group will not receive antibiotics. This randomized controlled trial compares these approaches to see if antibiotics improve delirium in this population. During the study, researchers will assess delirium at day 7 or when participants leave the hospital, whichever comes first. They will also monitor other outcomes like hospital stay length, blood infections, ICU transfers, falls, use of restraints or antipsychotics, antibiotic days, and infections such as C. difficile up to 30 days. Deaths and hospital readmissions will be tracked for up to one year. The study aims to provide clearer guidance on antibiotic use for delirium with suspected infection in older adults.
CONDITIONS
Brief Title
Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 or older and admitted to a hospital ward, including rehabilitation hospitals
- Active delirium diagnosed by CAM criteria or physician's diagnosis
- Less than 24 hours of antibiotic treatment before trial assessment
- Presence of pyuria (white blood cells in urine) or bacteriuria (bacteria in urine culture)
You will not qualify if you...
- Fever above 37.9°C (100.2°F) in the past 48 hours
- Symptoms of lower urinary tract infection (e.g., new pain during urination) or upper urinary symptoms (e.g., back tenderness)
- Physician believes antibiotics are needed for reasons other than delirium or urine test results (e.g., pneumonia)
- Indwelling urinary catheter used for more than 72 hours
- Received a single-dose antibiotic sufficient for urinary tract infection treatment, such as Fosfomycin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants are randomized to start or continue antibiotics as directed by their physician or to receive no antibiotics for treatment of bacteriuria.
Daily visits or assessments during hospital stay up to 7 days
Duration - Up to 365 days
Participants are monitored for outcomes including length of hospitalization, infections, readmissions, and survival up to 365 days after treatment.
Follow-up visits or contacts at 30 days and 365 days
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
Research Team
M
Michael Fralick, MD
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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