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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
550
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.
Participants will be randomized to no antibiotics
Northwestern Memorial Hospital
Chicago, Illinois, United States
NOT_YET_RECRUITINGThe Ottawa Hospital Civic Campus
Ottawa, Canada
NOT_YET_RECRUITINGThe Ottawa Hospital General Campus
Ottawa, Canada
NOT_YET_RECRUITINGHennick Bridgepoint Hospital
Toronto, Canada
NOT_YET_RECRUITINGMichael Garron Hospital
Toronto, Canada
RECRUITINGMount Sinai Hospital
Toronto, Canada
RECRUITINGToronto General Hospital
Toronto, Canada
NOT_YET_RECRUITINGDelirium 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 \[4\].
Time frame: Delirium will be assessed at the first of day 7 or discharge
Length of hospitalization
Time frame: Up to 30 days
Number of participants with bacteremia (bacteria isolated in blood culture)
Time frame: Up to 7 days
Number of participants who were transferred to Intensive Care Unit (ICU)
Time frame: Up to 7 days
Number of participants who had a fall
Time frame: Up to 7 days
Number of participants who were physically restrained
Time frame: Up to 7 days
Number of participants who received antipsychotics
Time frame: Up to 7 days
Days of antibiotics
Time frame: 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)
Time frame: By 30 days
Number of participants who died
Time frame: By 30 days
Number of participants who died
Time frame: By 365 days
Number of participants who were readmitted to hospital
Time frame: By 365 days
Number of participants who were readmitted to hospital
Time frame: By 30 days
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