Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection
- Conditions
- Infectious Disease
- Interventions
- Drug: Start Antibiotics / Continue Antibiotics for treatment of bacteriuriaOther: No Antibiotics for treatment of bacteriuria
- Registration Number
- NCT06004739
- Lead Sponsor
- Mount Sinai Hospital, Canada
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antibiotics Start Antibiotics / Continue Antibiotics for treatment of bacteriuria Participants will be randomized to start or continue with antibiotics. Antibiotic type and duration targeted to lower urinary tract infection as directed by the Most Responsible Physician (MRP). No Antibiotics No Antibiotics for treatment of bacteriuria Participants will be randomized to no antibiotics
- Primary Outcome Measures
Name Time Method 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 \[4\].
- Secondary Outcome Measures
Name Time Method Length of hospitalization Up to 30 days Number of participants with bacteremia (bacteria isolated in blood culture) Up to 7 days Number of participants who were transferred to Intensive Care Unit (ICU) Up to 7 days Number of participants who had a fall Up to 7 days Number of participants who received antipsychotics Up to 7 days Number of participants with C. difficile infection By 30 days C. difficile will be defined as a combination of a positive microbiological test for C. difficile (if still hospitalized at the time of diagnosis), or self-reported diagnosis of C. difficile (provided the patient reported diarrhea and receipt of an antibiotic to treat C. difficile)
Number of participants who died By 365 days Number of participants who were readmitted to hospital By 30 days Number of participants who were physically restrained Up to 7 days Days of antibiotics Up to 7 days
Trial Locations
- Locations (7)
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
The Ottawa Hospital Civic Campus
🇨🇦Ottawa, Canada
The Ottawa Hospital General Campus
🇨🇦Ottawa, Canada
Hennick Bridgepoint Hospital
🇨🇦Toronto, Canada
Michael Garron Hospital
🇨🇦Toronto, Canada
Mount Sinai Hospital
🇨🇦Toronto, Canada
Toronto General Hospital
🇨🇦Toronto, Canada