DIagnoSing Care hOme UTI Study
ConditionUrinary Tract Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Southampton
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Candidate POCTs for detecting UTI
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Southampton
Lead sponsor
University of Oxford
Collaborator
University of Bristol
Collaborator
Public Health Wales
Collaborator
Source ClinicalTrials.gov