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Anti-infective

Antibiotics for Delirium (A-DONUT Trial)

N/A

Recruiting

Led By Nathan Stall, MD, PhD

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 60 and admitted to a hospital ward (including rehabilitation hospital)

Be older than 18 years old

Must not have

Fever (temperature > 37.9C or > 100.2F) in the past 48 hours

Signs of lower urinary tract infection symptoms or upper urinary symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up by 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore if antibiotics help older adults with delirium and suspected infection.

Who is the study for?

This trial is for adults aged 60 or older who are hospitalized with active delirium but do not have clear symptoms of a urinary tract infection. They must have had less than 24 hours of antibiotics before the trial and show signs of bacteria or white blood cells in their urine. Those with fever, UTI symptoms, long-term catheters, or other reasons for antibiotic use can't join.

What is being tested?

The study aims to determine if giving antibiotics to older adults with delirium and suspected infection (due to bacteria in urine) helps improve their condition. It's a randomized controlled trial where some patients will receive antibiotics while others won't, to compare outcomes.

What are the potential side effects?

Potential side effects from taking antibiotics may include allergic reactions, gastrointestinal issues like diarrhea or nausea, risk of fungal infections due to altered body flora, and possibly increased resistance to antibiotics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 or older and have been admitted to a hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had a fever higher than 100.2F in the last 2 days.

Select...

I am experiencing symptoms of a urinary tract infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ by 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~by 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and by 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Delirium at day 7 or at day of hospital discharge, whichever is earliest

Secondary study objectives

Number of participants with C. difficile infection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: No AntibioticsExperimental Treatment1 Intervention

Participants will be randomized to no antibiotics

Group II: AntibioticsExperimental Treatment1 Intervention

Participants will be randomized to start or continue with antibiotics. Antibiotic type and duration targeted to lower urinary tract infection as directed by the Most Responsible Physician (MRP).

0 / 3Eligibility criteria met