Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection (A-DONUT)
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ClinicalTrials.gov Identifier: NCT06004739 |
Recruitment Status :
Recruiting
First Posted : August 22, 2023
Last Update Posted : April 25, 2024
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Condition or disease | Intervention/treatment | Phase |
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Infectious Disease | Drug: Start Antibiotics / Continue Antibiotics for treatment of bacteriuria Other: No Antibiotics for treatment of bacteriuria | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 550 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection |
Estimated Study Start Date : | April 2024 |
Estimated Primary Completion Date : | September 2027 |
Estimated Study Completion Date : | September 2027 |
Arm | Intervention/treatment |
---|---|
Antibiotics
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).
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Drug: Start Antibiotics / Continue Antibiotics for treatment of bacteriuria
Participants will be randomized to start or continue with antibiotics (with antibiotic duration determined by the Most Responsible Physician [MRP]). Antibiotics choice to be selected by the MRP. |
No Antibiotics
Participants will be randomized to no antibiotics
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Other: No Antibiotics for treatment of bacteriuria
Participants will be randomized to no antibiotics |
- Delirium at day 7 or at day of hospital discharge, whichever is earliest [ Time Frame: Delirium will be assessed at the first of day 7 or discharge ]Delirium will be assessed using Confusion Assessment Method (CAM) or 4 A's Test (4AT). CAM assesses 4 delirium features: [1] inattention, [2] acute and fluctuating level of consciousness, [3] disorganized thinking and [4] altered mental status. For a diagnosis of delirium by CAM, the patient must display feature [1] AND [2], AND EITHER [3] or [4]. The 4AT is scored from 0-12. A score of 4 or more suggests delirium.
- Length of hospitalization [ Time Frame: Up to 30 days ]
- Number of participants with bacteremia (bacteria isolated in blood culture) [ Time Frame: Up to 7 days ]
- Number of participants who were transferred to Intensive Care Unit (ICU) [ Time Frame: Up to 7 days ]
- Number of participants who had a fall [ Time Frame: Up to 7 days ]
- Number of participants who were physically restrained [ Time Frame: Up to 7 days ]
- Number of participants who received antipsychotics [ Time Frame: Up to 7 days ]
- Days of antibiotics [ Time Frame: Up to 7 days ]
- Number of participants with C. difficile infection [ Time Frame: By 30 days ]C. difficile will be defined as a combination of a positive microbiological test for C. difficile (if still hospitalized at the time of diagnosis), or self-reported diagnosis of C. difficile (provided the patient reported diarrhea and receipt of an antibiotic to treat C. difficile)
- Number of participants who died [ Time Frame: By 30 days ]
- Number of participants who died [ Time Frame: By 365 days ]
- Number of participants who were readmitted to hospital [ Time Frame: By 365 days ]
- Number of participants who were readmitted to hospital [ Time Frame: By 30 days ]
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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 defined by the 4AT score [www.the4at.com/]) 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06004739
Contact: Michael Fralick, MD | (416) 586-4800 | mike.fralick@mail.utoronto.ca |
Canada, Ontario | |
Sault Area Hospital | Recruiting |
Sault Ste. Marie, Ontario, Canada | |
Contact: Lucas Castellani |
Principal Investigator: | Michael Fralick, MD, PhD | Sinai Health System | |
Principal Investigator: | Chris Kandel, MD, PhD | Michael Garron Hospital |
Responsible Party: | Mount Sinai Hospital, Canada |
ClinicalTrials.gov Identifier: | NCT06004739 |
Other Study ID Numbers: |
CTO 4466 |
First Posted: | August 22, 2023 Key Record Dates |
Last Update Posted: | April 25, 2024 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Delirium Antibiotics Older adults Urinary Tract Infection |
Infections Urinary Tract Infections Communicable Diseases Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Neurocognitive Disorders Mental Disorders Urologic Diseases |
Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Disease Attributes Pathologic Processes Anti-Bacterial Agents Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents |