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

NCT ID: NCT06004739

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-18
• Study Completion Date: 2027-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: OTHER

Start Antibiotics / Continue Antibiotics for treatment of bacteriuria

Intervention Type: DRUG

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.

No Antibiotics

Participants will be randomized to no antibiotics

Group Type: OTHER

No Antibiotics for treatment of bacteriuria

Intervention Type: OTHER

Participants will be randomized to no antibiotics

Interventions

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.

Intervention Type: DRUG

No Antibiotics for treatment of bacteriuria

Participants will be randomized to no antibiotics

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• Fever (temperature > 37.9C or > 100.2F) in the past 48 hours;
• Signs of lower urinary tract infection symptoms (such as new dysuria) or upper urinary symptoms (such as costovertebral tenderness)
• In the opinion of the treating physician, there is a reason apart from delirium and urine test results to treat with antibiotics (e.g., pneumonia)
• Indwelling urinary catheter for > 72 hours
• Receipt of an antibiotic where a single dose suffices for the treatment of a UTI (such as Fosfomycin)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sault Area Hospital

OTHER

Sponsor Role: collaborator

Michael Garron Hospital

OTHER

Sponsor Role: collaborator

Unity Health Toronto

OTHER

Sponsor Role: collaborator

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

Northwestern Memorial Hospital

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Fralick, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sinai Health System

Chris Kandel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Michael Garron Hospital

Nathan Stall, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sinai Health System

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status: NOT_YET_RECRUITING

The Ottawa Hospital Civic Campus

Ottawa, , Canada

Site Status: NOT_YET_RECRUITING

The Ottawa Hospital General Campus

Ottawa, , Canada

Site Status: NOT_YET_RECRUITING

Hennick Bridgepoint Hospital

Toronto, , Canada

Site Status: NOT_YET_RECRUITING

Michael Garron Hospital

Toronto, , Canada

Site Status: RECRUITING

Mount Sinai Hospital

Toronto, , Canada

Site Status: RECRUITING

Toronto General Hospital

Toronto, , Canada

Site Status: NOT_YET_RECRUITING

Countries

United States; Canada

Central Contacts

Michael Fralick, MD

Role: CONTACT

mike.fralick@mail.utoronto.ca

(416) 586-4800

Facility Contacts

Ajay Bhasin, MD

Role: primary

Derek MacFadden, MD, PhD

Role: primary

Derek MacFadden, MD, PhD

Role: primary

Michael Fralick, MD

Role: primary

Christopher Kandel, MD

Role: primary

Michael Fralick, MD, PhD

Role: primary

Lauren Lapointe-Shaw, MD

Role: primary

Other Identifiers

CTO 4466

Identifier Type: -

Identifier Source: org_study_id