DIagnoSing Care hOme UTI Study

NCT ID: NCT05880329

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-03-31

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.

Detailed Description

This feasibility observational study will be conducted in four overlapping stages: recruiting a cohort of 100 care home residents (CHR) from up to 10 care homes across the Thames Valley and Wessex (Stage 1); collecting weekly repeated baseline urine samples from a subset of participants (without suspected UTI) (Stage 2); following all 100 participants for 6 months and collecting additional data on those who develop possible UTI (Stage 3), and interviewing participants, their families and care home staff about study feasibility and acceptability (Stage 4).

Stage 1 - Cohort recruitment and baseline data collection

Baseline assessments:

Following consent, baseline data will be collected including demographics, medical history, and a description of baseline functional ability. We will also collect a urine sample for baseline microbiological and urinary biomarker analyses for each participant.

Stage 2 - Repeat urine sampling cohort 25 CHR recruited in Stage 1 will be asked to provide weekly urine samples for four weeks. Urine samples will be sent for microbiological and urinary biomarker analyses.

CHR who develop a possible UTI during this stage will contribute to Stage 3 and will continue to have any remaining weekly samples collected if possible.

Stage 3 - Possible UTI episodes All 100 CHR recruited during Stage 1 will be followed for 6 months. Care home staff will be asked to alert the research team as soon as any participant in the cohort develops possible UTI. This would include any situation where care home staff have decided to consult with a healthcare professional because they have detected a change in the CHR or their urine and believe that a UTI is 'a likely cause'. This would not include residents who become acutely unwell from a source that is clearly not UTI at onset (e.g. chest or skin infection or cerebrovascular event).

Participants who experience possible UTI will have a 'symptomatic baseline' assessment and follow up visits at 14 and 28 days. A urine sample will be collected. If possible and this doesn't delay care, this will be before any treatment is initiated. Repeat urine samples will be collected at days 14 and 28.

Some of the urine taken at symptomatic baseline and day 28 will also be tested using one or more novel POCTs by a member of the research team.

Stage 4 - Qualitative sub-study We will conduct a qualitative evaluation to explore study acceptability and barriers and facilitators to study procedures. Care home staff, residents, and their families will be asked to participate in semi-structured interviews towards the end of the study period.

Conditions

Urinary Tract Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Care home residents

100 care home residents will be recruited and followed up for 6 months.

Candidate POCTs for detecting UTI

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Candidate POCTs for detecting UTI

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

University of Bristol

OTHER

Sponsor Role: collaborator

Public Health Wales

OTHER_GOV

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abigail Moore

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Nick Francis

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Solent NHS Trust

Southampton, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Abigail Moore

Role: CONTACT

abigail.moore@phc.ox.ac.uk

00441865289300

Nick Francis

Role: CONTACT

nick.francis@soton.ac.uk

Facility Contacts

Emma Searle

Role: primary

Other Identifiers

79003

Identifier Type: -

Identifier Source: org_study_id