Urinary Tract InfectionsDISCO UTINCT05880329
DIagnoSing Care hOme UTI Study
An observational study of Urinary Tract Infections, run by University of Southampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Candidate POCTs for detecting UTI
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Nick Francis contact
United Kingdom1 site, 1 recruiting
- Recruiting
Solent NHS Trust
Southampton
Emma Searle
About this study
Official title: Feasibility Cohort Study on Predictors of Diagnosis and Prognosis of Urine Infection in Care Home Residents: DIagnoSing Care hOme UTI Study
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.
Read more
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.
Read the 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
- Being tested
- Candidate POCTs for detecting UTI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candidate POCTs for detecting UTIDiagnostic test
POCT performance will be evaluated in participants who experience possible UTI.
| Study group | Role | What they receive |
|---|---|---|
| Care home residents | 100 care home residents will be recruited and followed up for 6 months. Receives: Diagnostic Test: Candidate POCTs for detecting UTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
As a feasibility study, there is no primary outcome measure.
Measured: Baseline
Secondary outcomes (20)
Proportion of care homes agreeing to participate when recruiting care homes as research sites.
Measured: Baseline
Proportion of residents screened that are eligible and proportion of eligible that are recruited.
Measured: Baseline
Proportion of baseline urine samples obtained from participants recruited (consented)
Measured: Baseline
Proportion of repeated urine samples obtained of those participating in Stage 2
Measured: 2, 3 and 4 weeks
Quality of urine samples obtained
Proportions of samples collected mid-stream clean catch, vs other collection techniques Proportions of samples contaminated (as reported by staff collecting samples) Proportions of samples with microbiological evidence of contamination
Measured: Through study completion, 6 months
Adherence to urine transport protocols
Time from sampling until receipt in laboratory Proportion recorded as stored refrigerated prior to transportation
Measured: Through study completion, 6 months
Proportion of residents that experience a possible UTI during the follow-up period that are reported to the research team.
Measured: Through study completion, 6 months
Proportion of residents with possible UTI that are not reported to the research team.
Measured: Assessed weekly through to study completion at 6 months
Proportion of residents with possible UTI in whom the following is obtained:
- Symptomatic baseline data on the characteristics of the possible UTI
- A urine sample at onset of possible UTI
- A urine sample prior to any antibiotic administration
- Follow-up data
- Follow-up urine samples at 14 and 28 days from symptom onset
Measured: Through study completion, 6 months
Using semi-structured interviews with qualitative analysis to describe the views of care home staff, participants and family members on:
- Barriers and facilitators to taking part in the study.
- Experience of obtaining/giving consent.
- Experience of being a participant/family member of a participant.
- Experience of giving/collecting urine samples including resident and staff willingness and capacity to obtain weekly urine samples.
- Experience of reporting a possible UTI to the study team and any barriers or facilitators to reporting in a timely fashion.
- The diagnosis of UTI and how this is determined in usual care
- The diagnosis of UTI and how this was determined during the study
- Additional tests including POCTs for UTI
Measured: Through study completion, 6 months
Participant baseline demographic characteristics predictive of subsequent possible UTI/clinical outcomes
Measured: Through study completion, 6 months
Participant clinical characteristics at point of possible UTI and association with clinical outcomes
Measured: Through study completion, 6 months
Changes in weekly sample microbiology
Description of any changes in the microbiological results of samples sent weekly from weeks 1-4
Measured: Baseline, 2, 3 and 4 weeks
Predictors of weekly sample microbiology and changes in microbiology
Including previous urine culture results, resident demographic characteristics, and sampling characteristics
Measured: Baseline, 2, 3 and 4 weeks
Association between asymptomatic bacteriuria at baseline or in weekly sampling and onset of possible UTI during follow up period
Measured: Through study completion, 6 months
Association of each urinary biomarker with asymptomatic bacteriuria
Assess whether concentration of biomarkers listed below is associated with asymptomatic bacteriuria:
Matrix metallopeptidase-9, neutrophil gelatinase associated lipocalin (NGAL), Interleukin , Interleukin 8, Interleukin 6, Interleukin 6, Interleukin 10, secretory IgA, and chemokine (C-X-C motif) ligand 1
Measured: Baseline
Urinary biomarker concentrations in urine samples from asymptomatic participants without bacteriuria
Matrix metallopeptidase-9, neutrophil gelatinase associated lipocalin (NGAL), Interleukin , Interleukin 8, Interleukin 6, Interleukin 6, Interleukin 10, secretory IgA, and chemokine (C-X-C motif) ligand 1
Measured: Baseline
Urinary biomarker concentrations in urine samples from possible UTI episodes
Matrix metallopeptidase-9, neutrophil gelatinase associated lipocalin (NGAL), Interleukin , Interleukin 8, Interleukin 6, Interleukin 6, Interleukin 10, secretory IgA, and chemokine (C-X-C motif) ligand 1
Measured: Through study completion, 6 months
Failure rate of the POCT in residents with possible UTI (no result or invalid result)
Measured: Through study completion, 6 months
Agreement between POCT result and laboratory enhanced culture result at symptom onset for each possible UTI episode, and at 28 days post symptom on set
Comparison to be made between each POCT result and the result from the enhanced culture carried out in the laboratory at symptomatic baseline and 28 day follow up of each possible UTI episode.
Measured: Through study completion, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, University of Bristol, Public Health Wales
- Responsible party
- Sponsor
- Investigators
- Abigail Moore, Principal investigator, University of OxfordNick Francis, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880329
- Sponsor's protocol ID
- 79003
- Acronym
- DISCO UTI
- Status last verified
- Jul 2024
- First submitted
- 7 Mar 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD at this stage.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Cohort Study on Predictors of Diagnosis and Prognosis of Urine Infection in Care Home Residents: DIagnoSing Care hOme UTI Study
- ClinicalTrials.gov ID
- NCT05880329
- Acronym / sponsor ID
- DISCO UTI / 79003
- Conditions
- Urinary Tract Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- University of Oxford, University of Bristol, Public Health Wales
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Care home residents | – | Diagnostic Test: Candidate POCTs for detecting UTI100 care home residents will be recruited and followed up for 6 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candidate POCTs for detecting UTIPOCT performance will be evaluated in participants who experience possible UTI. | Diagnostic test | Care home residents |
Primary outcome
As a feasibility study, there is no primary outcome measure.
Time frame: Baseline
20 secondary outcomes
Proportion of care homes agreeing to participate when recruiting care homes as research sites.
Time frame: Baseline
Proportion of residents screened that are eligible and proportion of eligible that are recruited.
Time frame: Baseline
Proportion of baseline urine samples obtained from participants recruited (consented)
Time frame: Baseline
Proportion of repeated urine samples obtained of those participating in Stage 2
Time frame: 2, 3 and 4 weeks
Quality of urine samples obtained
Time frame: Through study completion, 6 months
Adherence to urine transport protocols
Time frame: Through study completion, 6 months
Proportion of residents that experience a possible UTI during the follow-up period that are reported to the research team.
Time frame: Through study completion, 6 months
Proportion of residents with possible UTI that are not reported to the research team.
Time frame: Assessed weekly through to study completion at 6 months
Proportion of residents with possible UTI in whom the following is obtained:
Time frame: Through study completion, 6 months
Using semi-structured interviews with qualitative analysis to describe the views of care home staff, participants and family members on:
Time frame: Through study completion, 6 months
Participant baseline demographic characteristics predictive of subsequent possible UTI/clinical outcomes
Time frame: Through study completion, 6 months
Participant clinical characteristics at point of possible UTI and association with clinical outcomes
Time frame: Through study completion, 6 months
Changes in weekly sample microbiology
Time frame: Baseline, 2, 3 and 4 weeks
Predictors of weekly sample microbiology and changes in microbiology
Time frame: Baseline, 2, 3 and 4 weeks
Association between asymptomatic bacteriuria at baseline or in weekly sampling and onset of possible UTI during follow up period
Time frame: Through study completion, 6 months
Association of each urinary biomarker with asymptomatic bacteriuria
Time frame: Baseline
Urinary biomarker concentrations in urine samples from asymptomatic participants without bacteriuria
Time frame: Baseline
Urinary biomarker concentrations in urine samples from possible UTI episodes
Time frame: Through study completion, 6 months
Failure rate of the POCT in residents with possible UTI (no result or invalid result)
Time frame: Through study completion, 6 months
Agreement between POCT result and laboratory enhanced culture result at symptom onset for each possible UTI episode, and at 28 days post symptom on set
Time frame: Through study completion, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No. There is no plan to share IPD at this stage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Francis contact
Abigail Moore principal investigator
University of Oxford
Nick Francis principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abigail Moore (00441865289300, abigail.moore@phc.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
As a feasibility study, there is no primary outcome measure. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.