What is this study trying to find out about delirium in older adults?

This study is evaluating whether antibiotics help improve delirium in adults aged 60 and older who have bacteria in their urine but no clear urinary infection symptoms. Researchers want to understand if antibiotics benefit patients with delirium suspected to be related to infection. The study is sponsored by Mount Sinai Hospital in Canada and aims to guide treatment decisions for this condition.

Who may be eligible for this delirium clinical trial?

Adults aged 60 or older who are hospitalized with active delirium may be eligible. Participants must have bacteria or white blood cells in their urine but no recent fever or clear urinary infection symptoms. Both men and women can join. People who have had antibiotics for more than 24 hours or have certain other infections may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this delirium clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect that all treatments and assessments related to the study will be free of charge.

Actively Recruiting

Phase Not Applicable

Age: 60Years +

All Genders

ID06004739

Study of Antibiotic Use for Delirium in Adults Aged 60 and Older Without Clear Urinary Tract Infection

Led by Mount Sinai Hospital, Canada · Updated on 2024-09-19

550

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Delirium is a sudden state of confusion commonly seen in older adults admitted to hospitals, and identifying its cause quickly is important but often difficult. Infection may cause delirium, and many patients have bacteria in their urine, but bacteria alone do not always indicate a true infection. This trial studies whether antibiotics help treat delirium in adults aged 60 and older who have delirium and suspected urinary infection but no clear signs of urinary tract infection. Participants will be randomly assigned to one of two groups one group will start or continue taking antibiotics prescribed by their main doctor, with the antibiotic type and treatment length decided by the doctor. The other group will not receive antibiotics. This randomized controlled trial compares these approaches to see if antibiotics improve delirium in this population. During the study, researchers will assess delirium at day 7 or when participants leave the hospital, whichever comes first. They will also monitor other outcomes like hospital stay length, blood infections, ICU transfers, falls, use of restraints or antipsychotics, antibiotic days, and infections such as C. difficile up to 30 days. Deaths and hospital readmissions will be tracked for up to one year. The study aims to provide clearer guidance on antibiotic use for delirium with suspected infection in older adults.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 60Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 60 or older and admitted to a hospital ward, including rehabilitation hospitals
Active delirium diagnosed by CAM criteria or physician's diagnosis
Less than 24 hours of antibiotic treatment before trial assessment
Presence of pyuria (white blood cells in urine) or bacteriuria (bacteria in urine culture)

You will not qualify if you...

Fever above 37.9°C (100.2°F) in the past 48 hours
Symptoms of lower urinary tract infection (e.g., new pain during urination) or upper urinary symptoms (e.g., back tenderness)
Physician believes antibiotics are needed for reasons other than delirium or urine test results (e.g., pneumonia)
Indwelling urinary catheter used for more than 72 hours
Received a single-dose antibiotic sufficient for urinary tract infection treatment, such as Fosfomycin

Research Team

Michael Fralick, MD

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