Infectious DiseaseA-DONUTNCT06004739
Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection
A study testing Start Antibiotics / Continue Antibiotics for treatment of bacteriuria and No Antibiotics for treatment of bacteriuria in people with Infectious Disease, run by Mount Sinai Hospital, Canada at 7 sites in 2 countries.
Trial summary
Delirium is an acute confusional state that is experienced by many older adults who are admitted to hospital. To treat delirium the underlying cause needs to be identified promptly, but this is challenging. One of the potential causes of delirium is infection. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Start Antibiotics / Continue Antibiotics for treatment of bacteriuria and No Antibiotics for treatment of bacteriuria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 18 May 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Canada6 sites, 6 recruiting
- Not yet recruiting
The Ottawa Hospital Civic Campus
Ottawa
Derek MacFadden, MD, PhD
- Not yet recruiting
The Ottawa Hospital General Campus
Ottawa
Derek MacFadden, MD, PhD
- Not yet recruiting
Hennick Bridgepoint Hospital
Toronto
Michael Fralick, MD
- Recruiting
Michael Garron Hospital
Toronto
Christopher Kandel, MD
- Recruiting
Mount Sinai Hospital
Toronto
Michael Fralick, MD, PhD
- Not yet recruiting
Toronto General Hospital
Toronto
Lauren Lapointe-Shaw, MD
United States1 site, 1 recruiting
- Not yet recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Ajay Bhasin, MD
About this study
Delirium is an acute confusional state that is experienced by many older adults who are admitted to hospital. To treat delirium the underlying cause needs to be identified promptly, but this is challenging. One of the potential causes of delirium is infection. Urine tests show that most patients experiencing delirium have bacteria in their urine, however, bacteria in the urine is common among older adults, and does not automatically indicate an infection is present. As a result it is difficult to know whether a lower urinary tract infection is present as individuals with delirium are frequently unable to report clinical signs of infection - symptoms of pain or discomfort with urination, having to urinate more frequently or pelvic discomfort. Very often, individuals with delirium are treated with antibiotics despite the fact that it is unknown whether antibiotics help to improve delirium in cases where bacteria in the urine is present. This proposed study is a randomized controlled trial that will examine if adults (age 60 or older) with delirium and suspected infection benefit from taking antibiotics.
- Conditions
- Infectious Disease
- Being tested
- Start Antibiotics / Continue Antibiotics for treatment of bacteriuria, No Antibiotics for treatment of bacteriuria
- Keywords
- Delirium, Antibiotics, Older adults, Urinary Tract Infection
- Medical subject headings
- Communicable Diseases, Delirium, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Start Antibiotics / Continue Antibiotics for treatment of bacteriuriaDrug
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 for treatment of bacteriuriaOther
Participants will be randomized to no antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Other | 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). Receives: Drug: Start Antibiotics / Continue Antibiotics for treatment of bacteriuria |
| No Antibiotics | Other | Participants will be randomized to no antibiotics Receives: Other: No Antibiotics for treatment of bacteriuria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium at day 7 or at day of hospital discharge, whichever is earliest
Delirium will be assessed using Confusion Assessment Method (CAM). 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].
Measured: Delirium will be assessed at the first of day 7 or discharge
Secondary outcomes (12)
Length of hospitalization
Measured: Up to 30 days
Number of participants with bacteremia (bacteria isolated in blood culture)
Measured: Up to 7 days
Number of participants who were transferred to Intensive Care Unit (ICU)
Measured: Up to 7 days
Number of participants who had a fall
Measured: Up to 7 days
Number of participants who were physically restrained
Measured: Up to 7 days
Number of participants who received antipsychotics
Measured: Up to 7 days
Days of antibiotics
Measured: Up to 7 days
Number of participants with C. difficile infection
- 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)
Measured: By 30 days
Number of participants who died
Measured: By 30 days
Number of participants who died
Measured: By 365 days
Number of participants who were readmitted to hospital
Measured: By 365 days
Number of participants who were readmitted to hospital
Measured: By 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start18 May 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Sault Area Hospital, Michael Garron Hospital, Unity Health Toronto, The Ottawa Hospital, Northwestern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Michael Fralick, MD, PhD, Principal investigator, Sinai Health SystemChris Kandel, MD, PhD, Principal investigator, Michael Garron HospitalNathan Stall, MD, PhD, Principal investigator, Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004739
- Sponsor's protocol ID
- CTO 4466
- Acronym
- A-DONUT
- Status last verified
- Sep 2024
- First submitted
- 24 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT06004739
- Acronym / sponsor ID
- A-DONUT / CTO 4466
- Conditions
- Infectious Disease
- Keywords
- Delirium, Antibiotics, Older adults, Urinary Tract Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Sault Area Hospital, Michael Garron Hospital, Unity Health Toronto, The Ottawa Hospital, Northwestern Memorial Hospital
- Study start
- 18 May 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Delirium is an acute confusional state that is experienced by many older adults who are admitted to hospital. To treat delirium the underlying cause needs to be identified promptly, but this is challenging. One of the potential causes of delirium is infection. Urine tests show that most patients experiencing delirium have bacteria in their urine, however, bacteria in the urine is common among older adults, and does not automatically indicate an infection is present. As a result it is difficult to know whether a lower urinary tract infection is present as individuals with delirium are frequently unable to report clinical signs of infection - symptoms of pain or discomfort with urination, having to urinate more frequently or pelvic discomfort. Very often, individuals with delirium are treated with antibiotics despite the fact that it is unknown whether antibiotics help to improve delirium in cases where bacteria in the urine is present. This proposed study is a randomized controlled trial that will examine if adults (age 60 or older) with delirium and suspected infection benefit from taking antibiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | Other | Drug: Start Antibiotics / Continue Antibiotics for treatment of bacteriuriaParticipants 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). |
| No Antibiotics | Other | Other: No Antibiotics for treatment of bacteriuriaParticipants will be randomized to no antibiotics |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Start Antibiotics / Continue Antibiotics for treatment of bacteriuriaParticipants 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. | Drug | Antibiotics |
| No Antibiotics for treatment of bacteriuriaParticipants will be randomized to no antibiotics | Other | No Antibiotics |
Primary outcome
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). 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].
12 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Start Antibiotics / Continue Antibiotics for treatment of bacteriuria and No Antibiotics for treatment of bacteriuria in people with Infectious Disease, run by Mount Sinai Hospital, Canada at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Fralick, MD ((416) 586-4800, mike.fralick@mail.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.