Using antibiotics to treat delirium in older adults without clear urinary infections

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

This study tests whether giving antibiotics can help older adults with delirium feel better, even if they don't have a clear urinary infection.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 550 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Mount Sinai Hospital, Canada (Academic / other)
• Locations: 7 sites (Chicago, Illinois and 6 other locations)
• Trial ID: NCT06004739 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of antibiotics in treating delirium among older adults who show signs of bacteriuria but do not have clear urinary tract infections. It aims to determine whether administering antibiotics improves delirium symptoms in patients who are unable to communicate their discomfort. Participants will be randomly assigned to receive either antibiotics or no antibiotics, allowing researchers to assess the impact of antibiotic treatment on delirium outcomes. The study focuses on older adults aged 60 and above who are admitted to hospitals and diagnosed with active delirium.

Who should consider this trial

Good fit: Ideal candidates for this study are older adults aged 60 and above who are hospitalized with active delirium and show signs of bacteriuria.

Not a fit: Patients who have clear signs of urinary tract infections or other infections requiring antibiotic treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment protocols for delirium in older adults, potentially improving patient outcomes and reducing unnecessary antibiotic use.

How similar studies have performed: While the approach of using antibiotics for delirium in the absence of clear infections is novel, similar studies have explored the treatment of delirium, but this specific focus on bacteriuria is less common.

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)

Where this trial is running

Chicago, Illinois and 6 other locations

• Northwestern Memorial Hospital — Chicago, Illinois, 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)

Study contacts

• Principal investigator: Michael Fralick, MD, PhD — Sinai Health System
• Study coordinator: Michael Fralick, MD

Conditions Infectious Disease; Delirium; Antibiotics; Older adults; Urinary Tract Infection