Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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 population

We aim to recruit a cohort of 100 care home residents over 65 years of age from up to 10 care home sites.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Candidate POCTs for detecting UTI

    Diagnostic test

    POCT performance will be evaluated in participants who experience possible UTI.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Care home residents1 intervention

Trial outcomes

Primary outcomes

1

As a feasibility study, there is no primary outcome measure.

Time frame
Baseline

Secondary outcomes

1

Proportion of care homes agreeing to participate when recruiting care homes as research sites.

Time frame
Baseline
2

Proportion of residents screened that are eligible and proportion of eligible that are recruited.

Time frame
Baseline
3

Proportion of baseline urine samples obtained from participants recruited (consented)

Time frame
Baseline
4

Proportion of repeated urine samples obtained of those participating in Stage 2

Time frame
2, 3 and 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southampton

Lead sponsor

University of Oxford

Collaborator

University of Bristol

Collaborator

Public Health Wales

Collaborator

Source ClinicalTrials.gov
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