NCT06004739

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

• Infectious Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-18
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2023-08-22
• Last updated: 2024-09-19

Locations

7 sites across 2 countries: United States, Canada