Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection
NCT06004739 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550
Last updated 2024-09-19
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.
Conditions
Interventions
- DRUG
-
Start Antibiotics / Continue Antibiotics for treatment of bacteriuria
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.
- OTHER
-
No Antibiotics for treatment of bacteriuria
Participants will be randomized to no antibiotics
Sponsors & Collaborators
-
Sault Area Hospital
collaborator OTHER -
Michael Garron Hospital
collaborator OTHER -
Unity Health Toronto
collaborator OTHER -
The Ottawa Hospital
collaborator OTHER -
Northwestern Memorial Hospital
collaborator OTHER -
Mount Sinai Hospital, Canada
lead OTHER
Principal Investigators
-
Michael Fralick, MD, PhD · Sinai Health System
-
Chris Kandel, MD, PhD · Michael Garron Hospital
-
Nathan Stall, MD, PhD · Sinai Health System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-18
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
Countries
- United States
- Canada
Study Locations
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