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

NCT06004739 | Recruiting DMC

• 1 other identifier: CTO 4466
• Study Type: interventional
• Target: 550
• Locations: 2 countries
• Sites: 7

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

Keywords

Delirium; Antibiotics; Older adults; Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Delirium at day 7 or at day of hospital discharge, whichever is earliest

  Delirium will be assessed using Confusion Assessment Method (CAM). CAM assesses 4 delirium features: \[1\] inattention, \[2\] acute and fluctuating level of consciousness, \[3\] disorganized thinking and \[4\] altered mental status. For a diagnosis of delirium by CAM, the patient must display feature \[1\] AND \[2\], AND EITHER \[3\] or \[4\].

  Delirium will be assessed at the first of day 7 or discharge

Secondary Outcomes (12)

• Length of hospitalization

  Up to 30 days

• Number of participants with bacteremia (bacteria isolated in blood culture)

  Up to 7 days

• Number of participants who were transferred to Intensive Care Unit (ICU)

  Up to 7 days

• Number of participants who had a fall

  Up to 7 days

• Number of participants who were physically restrained

  Up to 7 days

Study Arms (2)

Antibiotics

OTHER

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).

Drug: Start Antibiotics / Continue Antibiotics for treatment of bacteriuria

No Antibiotics

OTHER

Participants will be randomized to no antibiotics

Other: No Antibiotics for treatment of bacteriuria

Interventions

Start Antibiotics / Continue Antibiotics for treatment of bacteriuria 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.

Antibiotics

No Antibiotics for treatment of bacteriuria OTHER

Participants will be randomized to no antibiotics

No Antibiotics

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Sault Area Hospital: collaborator
• Michael Garron Hospital: collaborator
• Unity Health Toronto: collaborator
• The Ottawa Hospital: collaborator
• Northwestern Memorial Hospital: collaborator

Study Sites (7)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

The Ottawa Hospital Civic Campus

Ottawa, Canada

NOT YET RECRUITING

The Ottawa Hospital General Campus

Ottawa, Canada

NOT YET RECRUITING

Hennick Bridgepoint Hospital

Toronto, Canada

NOT YET RECRUITING

Michael Garron Hospital

Toronto, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Canada

RECRUITING

Toronto General Hospital

Toronto, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Communicable Diseases; Delirium; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Michael Fralick, MD, PhD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

• Chris Kandel, MD, PhD

  Michael Garron Hospital

  PRINCIPAL INVESTIGATOR

• Nathan Stall, MD, PhD

  Sinai Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Fralick, MD

CONTACT

(416) 586-4800; mike.fralick@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 22, 2023
• Study Start: May 18, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6); US (1)