NCT06004739 Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection
| NCT ID | NCT06004739 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mount Sinai Hospital, Canada |
| Condition | Infectious Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 550 participants |
| Start Date | 2024-05-18 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 550 participants in total. It began in 2024-05-18 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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 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 * Receipt of an antibiotic where a single dose suffices for the treatment of a UTI (such as Fosfomycin)
Contact & Investigator
Michael Fralick, MD, PhD
PRINCIPAL INVESTIGATOR
Sinai Health System
Frequently Asked Questions
Who can join the NCT06004739 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Infectious Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06004739 currently recruiting?
Yes, NCT06004739 is actively recruiting participants. Contact the research team at mike.fralick@mail.utoronto.ca for enrollment information.
Where is the NCT06004739 trial being conducted?
This trial is being conducted at Chicago, United States, Ottawa, Canada, Ottawa, Canada, Toronto, Canada and 3 additional locations.
Who is sponsoring the NCT06004739 clinical trial?
NCT06004739 is sponsored by Mount Sinai Hospital, Canada. The principal investigator is Michael Fralick, MD, PhD at Sinai Health System. The trial plans to enroll 550 participants.