| NCT ID | NCT05880329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Southampton |
| Condition | Urinary Tract Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-09-01 with a primary completion date of 2024-12-31.
⚠ 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
The number of care home residents is increasing and urinary tract infections (UTIs) are common amongst this group. Accurate diagnosis of UTI is important because not treating an infection may lead to serious consequences including death. However, giving antibiotic treatment when there isn't an infection causes side effects and antibiotic resistance, making future infections harder to treat. Unfortunately, there are several challenges that mean that it is difficult to diagnose UTI accurately in care home residents. Firstly, UTIs don't always cause clear symptoms for people who live in care homes. They sometimes just cause symptoms like confusion which can have lots of different possible causes. Secondly, it may be hard for people living with dementia to say how they are feeling or to easily provide a urine sample. Thirdly, many people who live in care homes have bacteria present in their urine even when they are well, but this not harmful and does not need treatment. Finally, urine tests that are currently available do not give accurate or quick results. We have thought about some new ways that might help show us if someone in a care home really has a UTI but we don't know yet whether these will work. Our ideas include 1) Working out which symptoms or signs mean a UTI is more likely 2) Detecting new markers of infection in urine samples and 3) Trying out new bedside tests that give rapid results. For this study we plan to recruit 100 care home residents who will be followed up over 6 months. All 100 participants will provide information and a urine sample at the beginning of the study. 25 of these participants will also provide repeated weekly samples for 4 weeks to look at any changes in the urine over time. Additional information and urine samples will be collected if a participant develops a possible UTI during the study and any treatments will be recorded. Our findings will be used to develop a funding application for a larger study aiming to improve the diagnosis of UTI in care home residents.
Eligibility Criteria
Inclusion Criteria: * Willing and able to give informed consent for the study, or if lacking capacity, a consultee willing to complete a consultee declaration form. * Permanently living in a care home (nursing, residential or mixed). * Aged 65 or over. Exclusion Criteria: * Current/recent suspected UTI (within last 4 weeks). However, may be reassessed for eligibility after 4 weeks. * Temporary/respite resident (unlikely to remain living in the care home for the 6 months of the study duration) * Terminal illness limiting life expectancy such that inclusion would be inappropriate (as judged by care home staff). * Known to have a medical condition or be on treatment that is likely to result in severe impairment of the immune system. For example, neutropenia, recent cancer chemotherapy or radiotherapy, or long-term use of oral steroids or other immunosuppressant medication. * Experiencing faecal incontinence to the extent that it is impossible to obtain an uncontaminated urine sample (as determined by care home staff). * Indwelling urinary catheter or regular use of intermittent catheterisation. * Structural urological abnormalities. For example, renal polycystic disease, horseshoe kidney, hydronephrosis, renal hypoplasia * Current renal tract malignancy. However, residents with prostate cancer will be eligible if they do not require catheterisation and are not considered terminally ill.
Contact & Investigator
Abigail Moore
PRINCIPAL INVESTIGATOR
University of Oxford
Frequently Asked Questions
Who can join the NCT05880329 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Urinary Tract Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05880329 currently recruiting?
Yes, NCT05880329 is actively recruiting participants. Contact the research team at abigail.moore@phc.ox.ac.uk for enrollment information.
Where is the NCT05880329 trial being conducted?
This trial is being conducted at Southampton, United Kingdom.
Who is sponsoring the NCT05880329 clinical trial?
NCT05880329 is sponsored by University of Southampton. The principal investigator is Abigail Moore at University of Oxford. The trial plans to enroll 100 participants.