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Anti-infective
Antibiotics for Delirium (A-DONUT Trial)
N/A
Recruiting
Led By Michael Fralick, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by 365 days
Awards & highlights
A-DONUT Trial 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.Check my eligibility
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.See study design
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.
A-DONUT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 or older and have been admitted to a hospital.
A-DONUT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ by 365 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by 365 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Delirium at day 7 or at day of hospital discharge, whichever is earliest
Secondary outcome measures
Days of antibiotics
Length of hospitalization
Number of participants who died
+7 moreA-DONUT 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).
Find a Location
Who is running the clinical trial?
Sault Area HospitalOTHER
4 Previous Clinical Trials
665 Total Patients Enrolled
Michael Garron HospitalOTHER
13 Previous Clinical Trials
4,162 Total Patients Enrolled
Mount Sinai Hospital, CanadaLead Sponsor
196 Previous Clinical Trials
67,058 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for individuals to participate in this trial?
"Authentic. According to information on clinicaltrials.gov, this experiment is currently recruiting participants and was initially posted on September 1st 2023. The trial requires approximately 550 individuals from one centre of research."
Answered by AI
How many participants have been accepted to this research project?
"Affirmative. Data published on clinicaltrials.gov attests that this research, initially posted on September 1st 2023, is currently recruiting patients. A total of 550 participants are required at one medical centre for the study to be completed successfully."
Answered by AI
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