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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Age ≥ 60 and admitted to a hospital ward (including rehabilitation hospital);

• Active delirium (defined by CAM: \[1\] inattention AND \[2\] acute and fluctuating level of consciousness, and either \[3\] disorganized thinking OR \[4\] altered mental status; OR physician's diagnosis)

• Less than 24 hours of antibiotics (prior to trial assessment)

• Either pyuria (defined as white blood cells detected on urinalysis or dipstick) or bacteriuria (defined as bacteria growing on urine culture)

Locations
United States
Illinois
Northwestern Memorial Hospital
NOT_YET_RECRUITING
Chicago
Other Locations
Canada
The Ottawa Hospital Civic Campus
NOT_YET_RECRUITING
Ottawa
The Ottawa Hospital General Campus
NOT_YET_RECRUITING
Ottawa
Hennick Bridgepoint Hospital
NOT_YET_RECRUITING
Toronto
Michael Garron Hospital
RECRUITING
Toronto
Mount Sinai Hospital
RECRUITING
Toronto
Toronto General Hospital
NOT_YET_RECRUITING
Toronto
Contact Information
Primary
Michael Fralick, MD
mike.fralick@mail.utoronto.ca
(416) 586-4800
Time Frame
Start Date: 2024-05-18
Estimated Completion Date: 2027-09
Participants
Target number of participants: 550
Treatments
Other: Antibiotics
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).
Other: No Antibiotics
Participants will be randomized to no antibiotics
Related Therapeutic Areas
Sponsors
Collaborators: Northwestern Memorial Hospital, Michael Garron Hospital, The Ottawa Hospital, Sault Area Hospital, Unity Health Toronto
Leads: Mount Sinai Hospital, Canada

This content was sourced from clinicaltrials.gov