DIagnoSing Care hOme UTI Study

NCT05880329 | Recruiting

• 1 other identifier: 79003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

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

  Baseline

Secondary Outcomes (20)

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

  Baseline

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

  Baseline

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

  Baseline

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

  2, 3 and 4 weeks

• Quality of urine samples obtained

  Through study completion, 6 months

Study Arms (1)

Care home residents

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

Diagnostic Test: Candidate POCTs for detecting UTI

Interventions

Candidate POCTs for detecting UTI DIAGNOSTIC_TEST

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

Care home residents

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• University of Southampton: lead
• University of Oxford: collaborator
• University of Bristol: collaborator
• Public Health Wales: collaborator

Study Sites (1)

Solent NHS Trust

Southampton, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples. We intend to seek further funding to complete pilot sequencing work on the urine microbiome from some of the samples collected, including any carriage of antimicrobial resistance genes. After use in DISCO UTI, samples would be spun and frozen, then couriered and stored at the University of Oxford.

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Abigail Moore

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Nick Francis

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Moore

CONTACT

00441865289300; abigail.moore@phc.ox.ac.uk

Nick Francis

CONTACT

nick.francis@soton.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: May 30, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)