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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Michael Garron Hospital
  Toronto, Canada Recruiting
• Mount Sinai Hospital
  Toronto, Canada Recruiting
• 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

Study contacts

• Principal investigator: Michael Fralick, MD, PhD — Sinai Health System
• Study coordinator: Michael Fralick, MD
• Email: mike.fralick@mail.utoronto.ca
• Phone: (416) 586-4800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.