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Search / Trial NCT06004739

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

Launched by MOUNT SINAI HOSPITAL, CANADA · Aug 21, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Delirium Antibiotics Older Adults Urinary Tract Infection

ClinConnect Summary

This clinical trial is studying whether antibiotics can help improve delirium in older adults who are suspected of having an infection but do not have clear signs of a urinary tract infection. Delirium is a sudden state of confusion that is common in older patients, especially when they are in the hospital. While many patients with delirium have bacteria in their urine, it doesn't always mean they have an infection that needs antibiotics. The goal of this study is to find out if giving antibiotics to these patients makes a difference in their recovery from delirium.

To participate in this trial, you need to be at least 60 years old and currently in the hospital with active delirium. You should have been in the hospital for less than 24 hours and have certain findings in your urine tests. However, if you have a fever, signs of a urinary infection, or other specific medical conditions, you may not be eligible. If you join the trial, you will be randomly assigned to either receive antibiotics or not, and your progress will be monitored to see how well you improve. This research is important because it will help doctors understand whether antibiotics are useful for treating delirium in these situations.

Gender

ALL

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)

About Mount Sinai Hospital, Canada

Mount Sinai Hospital, located in Canada, is a leading academic health institution renowned for its commitment to innovative research and high-quality patient care. As a sponsor of clinical trials, Mount Sinai Hospital leverages its extensive expertise in various medical disciplines to advance clinical knowledge and develop new therapies. The hospital collaborates with a diverse network of healthcare professionals, researchers, and institutions to conduct rigorous trials that aim to improve health outcomes and enhance the quality of life for patients. With a focus on ethical standards and patient safety, Mount Sinai Hospital is dedicated to translating scientific discoveries into effective clinical practices.

Locations

Chicago, Illinois, United States

Toronto, Ontario, Canada

Toronto, , Canada

Sault Ste. Marie, Ontario, Canada

Ottawa, , Canada

Ottawa, , Canada

Toronto, , Canada

Toronto, , Canada

Patients applied

0 patients applied

Trial Officials

Michael Fralick, MD, PhD

Principal Investigator

Sinai Health System

Chris Kandel, MD, PhD

Principal Investigator

Michael Garron Hospital

Nathan Stall, MD, PhD

Principal Investigator

Sinai Health System

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported