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| Name | Class |
|---|---|
| Sault Area Hospital | OTHER |
| Michael Garron Hospital | OTHER |
| Unity Health Toronto | OTHER |
| The Ottawa Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics | Other | 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 | Other | Participants will be randomized to no antibiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Start Antibiotics / Continue Antibiotics for treatment of bacteriuria | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium at day 7 or at day of hospital discharge, whichever is earliest | 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]. | Delirium will be assessed at the first of day 7 or discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Fralick, MD | Contact | (416) 586-4800 | mike.fralick@mail.utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael Fralick, MD, PhD | Sinai Health System | Principal Investigator |
| Chris Kandel, MD, PhD | Michael Garron Hospital | Principal Investigator |
| Nathan Stall, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Not yet recruiting | Chicago | Illinois | 60611 | United States |
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| OTHER |
| Northwestern Memorial Hospital | OTHER |
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| No Antibiotics for treatment of bacteriuria | Other | Participants will be randomized to no antibiotics |
|
| Up to 7 days |
| Number of participants who had a fall | Up to 7 days |
| Number of participants who were physically restrained | Up to 7 days |
| Number of participants who received antipsychotics | Up to 7 days |
| Days of antibiotics | Up to 7 days |
| Number of participants with C. difficile infection | 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) | By 30 days |
| Number of participants who died | By 30 days |
| Number of participants who died | By 365 days |
| Number of participants who were readmitted to hospital | By 365 days |
| Number of participants who were readmitted to hospital | By 30 days |
| Sinai Health System |
| Principal Investigator |
| The Ottawa Hospital Civic Campus | Not yet recruiting | Ottawa | Canada |
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| The Ottawa Hospital General Campus | Not yet recruiting | Ottawa | Canada |
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| Hennick Bridgepoint Hospital | Not yet recruiting | Toronto | Canada |
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| Michael Garron Hospital | Recruiting | Toronto | Canada |
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| Mount Sinai Hospital | Recruiting | Toronto | Canada |
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| Toronto General Hospital | Not yet recruiting | Toronto | Canada |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D003693 | Delirium |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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