Clinical trial NCT06004739: Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection
Official title: Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infectious Disease
Keywords: Delirium
Antibiotics
Older adults
Urinary Tract Infection
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Sault Area Hospital
name: Michael Garron Hospital
name: Unity Health Toronto
name: The Ottawa Hospital
name: Northwestern Memorial Hospital
First posted: 2023-08-22
Enrollment: 550
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Delirium at day 7 or at day of hospital discharge, whichever is earliest
timeFrame: Delirium will be assessed at the first of day 7 or discharge
Secondary outcomes:
measure: Length of hospitalization
timeFrame: Up to 30 days
measure: Number of participants with bacteremia (bacteria isolated in blood culture)
timeFrame: Up to 7 days
measure: Number of participants who were transferred to Intensive Care Unit (ICU)
timeFrame: Up to 7 days
measure: Number of participants who had a fall
timeFrame: Up to 7 days
measure: Number of participants who were physically restrained
timeFrame: Up to 7 days
measure: Number of participants who received antipsychotics
timeFrame: Up to 7 days
measure: Days of antibiotics
timeFrame: Up to 7 days
measure: Number of participants with C. difficile infection
timeFrame: By 30 days
measure: Number of participants who died
timeFrame: By 30 days
measure: Number of participants who died
timeFrame: By 365 days
measure: Number of participants who were readmitted to hospital
timeFrame: By 365 days
measure: Number of participants who were readmitted to hospital
timeFrame: By 30 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Ottawa
country: Canada
facility: The Ottawa Hospital Civic Campus
city: Ottawa
country: Canada
facility: The Ottawa Hospital General Campus
city: Toronto
country: Canada
facility: Hennick Bridgepoint Hospital
city: Toronto
country: Canada
facility: Michael Garron Hospital
city: Toronto
country: Canada
facility: Mount Sinai Hospital
city: Toronto
country: Canada
facility: Toronto General Hospital
Study officials:
affiliation: Sinai Health System
name: Michael Fralick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michael Garron Hospital
name: Chris Kandel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinai Health System
name: Nathan Stall, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: