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

Infectious Disease Clinical Trial

— A-DONUT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004739
• Other study ID #: CTO 4466
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2027

Study information

• Verified date: July 2023
• Source: Mount Sinai Hospital, Canada
• Contact: Michael Fralick, MD
• Phone: (416) 586-4800
• Email: mike.fralick[@]mail.utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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 defined by the 4AT score [www.the4at.com/]) 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

Related Conditions & MeSH terms

• Communicable Diseases
• Delirium
• Infections
• Infectious Disease
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
Canada	Sault Area Hospital	Sault Ste. Marie	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Michael Garron Hospital, Sault Area Hospital, The Ottawa Hospital, Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium at day 7 or at day of hospital discharge, whichever is earliest	Delirium will be assessed using Confusion Assessment Method (CAM) or 4 A's Test (4AT). 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]. The 4AT is scored from 0-12. A score of 4 or more suggests delirium.	Delirium will be assessed at the first of day 7 or discharge
Secondary	Length of hospitalization		Up to 30 days
Secondary	Number of participants with bacteremia (bacteria isolated in blood culture)		Up to 7 days
Secondary	Number of participants who were transferred to Intensive Care Unit (ICU)		Up to 7 days
Secondary	Number of participants who had a fall		Up to 7 days
Secondary	Number of participants who were physically restrained		Up to 7 days
Secondary	Number of participants who received antipsychotics		Up to 7 days
Secondary	Days of antibiotics		Up to 7 days
Secondary	Number of participants with C. difficile infection	C. difficile will be defined as a combination of a positive microbiological test for C. difficile (if still hospitalized at the time of diagnosis), or self-reported diagnosis of C. difficile (provided the patient reported diarrhea and receipt of an antibiotic to treat C. difficile)	By 30 days
Secondary	Number of participants who died		By 30 days
Secondary	Number of participants who died		By 365 days
Secondary	Number of participants who were readmitted to hospital		By 365 days
Secondary	Number of participants who were readmitted to hospital		By 30 days