Clinical Trial

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

Study acronym: A-DONUT
Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-08-21; most recent amendment 2024-09-09.
Status change: Not Yet Recruiting → Recruiting 2023-08-30
Trial Details
NCT Number NCT06004739
Lead Sponsor Mount Sinai Hospital, Canada
Collaborators: Sault Area Hospital, Michael Garron Hospital, Unity Health Toronto, The Ottawa Hospital, Northwestern Memorial Hospital
Conditions Infectious Disease
Enrollment 550 participants
Start Date 2024-05-18
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2024-09-19