Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000613707
Ethics application status
Approved
Date submitted
1/04/2022
Date registered
26/04/2022
Date last updated
5/04/2023
Date data sharing statement initially provided
26/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
3PU: Development of a novel diagnostic tool aimed at prediction, prognosis and prevention of urinary tract infections (UTIs) in spinal cord injury people who use catheters for bladder management
Scientific title
Metagenomics-based diagnostics for the prediction, prognosis and prevention of urinary tract infections in patients who use catheters for bladder management
Secondary ID [1] 306821 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
3PU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
catheter associated UTI 325904 0
Condition category
Condition code
Infection 323215 323215 0 0
Studies of infection and infectious agents
Neurological 323216 323216 0 0
Other neurological disorders
Injuries and Accidents 323218 323218 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
-Catheter and urine collection, standard culturing and analysis of clinically relevant samples and participant histories.

First part of the clinical study is designed to have samples collected monthly over 18 months and will be accompanied with a standardised assessment of UTI symptoms, health related quality of life and utility. The sample collection will be done alongside participant’s routine care and only collect samples that would otherwise be discarded. Catheter change based on participants routine care is collected specifically trained surgical dressers, nurses or carers at outpatient clinics, patients home, or G.P surgery. This involves collection of participant’s used catheter and urine sample provided from the newly changed catheter coinciding where possible with the patient’s regular catheter change (typically monthly) for analysis in the research lab. If someone was having regular 4 or 6 weekly catheter changes routinely, we would try to leave their current system in place, so no change to their standard therapy takes place other than collection urine and the catheter after the change. This should not increase their risk of a UTI. If someone was having catheter changes more than monthly, for example weekly, we would ask for every 4th catheter to be collected.

At the baseline and first UTI event the collected urine samples will also be send to pathology lab for routine pathology tests. The participants clinicians are kept blinded from the baseline information unless the information is specifically requested. The reason for this is because the standard of care for the treatment of Spinal Cord Injury urinary tract infection (UTI) is to NOT treat asymptomatic bacteriuria and by definition this is what the baseline urine represents. The blinding is to prevent treatment of asymptomatic UTI which would contribute to community antibiotic resistance.

If the participant feels they might have symptoms that may indicate UTI they will be asked to contact their usual medical practitioner or the study clinician to initiate treating of the suspected UTI. They will also be asked to provide extra samples of urine and along with 5cm of the tip of the old catheter (including the balloon) for DNA analysis. An information form would need to be completed by the person explanting the catheter in consultation with the patient and will also include the proceduralist’s contact number.
If the participant is providing the samples at one of the spinal cord injury clinics related to this study Prince Of Wales Hospital (POWH), Royal North Shore Hospital (RNSH), Royal Rehab (RR) and Fairfield West clinic, a nurse or research team member will ask the participant to fill in the catheter package form and Health status questionnaire as well as arrange for the samples to be sent to the research lab. If the participants are changing their own catheter at home or at their personal practitioner’s office, we will send them the catheter package. The catheter package consisting of a polystyrene box with pre-labelled specimen containers, catheter package form and health status questionnaire will be provided by the research team that can stored in 4°C for up to 24 h or at clinic room temperature for 4 hours. Batch or individual samples may be delivered by clinical or research staff or courier, according to our established protocols. The health status questionnaire (EQ-5D-5L self-assessment of personal health) (Compare the Base line to 1 year ago and after that reference last reported healthy state timeline) is collected on a monthly basis at the same time as sample catheter collection. If the patient needs assistance in completing questionnaires, a research associate will contact them to fill the survey via telephone. A proxy may assist the participant with manual form completion under the direction of the participant. A research associate will contact outpatients by telephone to assess their personal health at two weeks post catheter change. We estimate 30 minutes of participant time in order to complete the questionnaires and phone information every month.
Intervention code [1] 323286 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330965 0
Detection of shift in each participants microbiome during UTI event compared to the non symptomatic period using microbial community analysis (metagenome sequencing) of the entire bacterial community of biofilm in used catheter and fresh catch urine samples
Timepoint [1] 330965 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [1] 408304 0
Assessment of personal health and utility EQ-5D-5L on asymptomatic catheter change and in the event of UTIs
Timepoint [1] 408304 0
Cumulative data will be assessed at the conclusion of the study

Eligibility
Key inclusion criteria
1. Adults, age 18 years and older;
2. Had a known neurogenic bladder;
3. Had a stable SCI or stable multiple sclerosis with a known spinal demyelinating lesion;
4. Had a stable bladder management technique [i.e. not expected to change their bladder management technique, and having performed their (stable) bladder management technique for at least 4 weeks] and using a bladder management technique such as indwelling catheter, suprapubic catheter, clean intermittent self-catheterisation or reflex/condom drainage;
5. Agreed to fortnightly telephone consultation for themselves and their care team during the eighteen month study period;
6. Agreed that the microbial community and the microbiome DNA from the catheter and urine samples you provide to be extracted and stored long-term.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Expected to change their bladder management technique or changed bladder management technique for less than at least 4 weeks
2. External condom drainage (ECD) is the only type of catheter used (ECD alongside intermittent catheter (IMC) is allowed)
3. Being treated for, or symptomatic from a current infection or longstanding pressure sore;
4. Known to have a complex bladder disturbance requiring surgical intervention e.g. known cystoplasty, renal or bladder calculus, significant hydronephrosis, or current pyelonephritis;
5. Known to have chronic open wound/s or known longstanding osteomyelitis [greater than 6 weeks];
6. On long-term antibiotic therapy for any indication;
7. Known to have severe renal or hepatic failure;
8. Requiring full [invasive] mechanical ventilation;
9. Receiving immunosuppressant medications or have an underlying immunosuppressive disease [for example HIV or endstage/Progressive diabetes mellitus, multiple sclerosis or cerebrovascular disease];
10. Concurrently enrolled in an intervention study which involves probiotics, bladder instrumentation, antibiotics of any sort or involving medications which would suppress the immune system; (observational studies or inclusion following completion of another study is allowed).

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The number of patients to be enrolled was based on the variability we observed in our preliminary work with three patients as well as the expected UTI rate of 1.8 per year (based on work by Waites et al. 1993), we would therefore expect 2.4 UTI episodes for each person during the study. Studies in the literature investigating the stability of the urinary tract, and other human microbiomes, vary dramatically in cohort size, 3 to >150. We therefore took an approximate median number of patient samples (n=60) and a longer time frame (18 month) for monitoring to ensure we would capture multiple episodes in our study population for more robust analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/11/2021
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
60
Accrual to date
27
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22101 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 22102 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 22103 0
Royal Rehab - Ryde - Ryde
Recruitment postcode(s) [1] 37225 0
2065 - St Leonards
Recruitment postcode(s) [2] 37226 0
2031 - Randwick
Recruitment postcode(s) [3] 37227 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 311155 0
Government body
Name [1] 311155 0
Spinal cord injury grant scheme- NSW health
Country [1] 311155 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo NSW 2007, Australia
Country
Australia
Secondary sponsor category [1] 312506 0
None
Name [1] 312506 0
Address [1] 312506 0
Country [1] 312506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310683 0
Northern Sydney Local Health District HREC
Ethics committee address [1] 310683 0
Ethics committee country [1] 310683 0
Australia
Date submitted for ethics approval [1] 310683 0
Approval date [1] 310683 0
06/04/2021
Ethics approval number [1] 310683 0
2021/ETH00329

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118506 0
Dr Bonsan Bonne Lee
Address 118506 0
Rehabilitation and Spinal Medicine Unit, Level 1, Clinical Sciences Building (Building 8), High street, Prince of Wales hospital, Randwick, NSW 2031
Country 118506 0
Australia
Phone 118506 0
+61 415296535
Fax 118506 0
Email 118506 0
[email protected]
Contact person for public queries
Name 118507 0
Parisa Noorian
Address 118507 0
Dr Parisa Noorian
UTS Science Store
Building 1, Level 2, Thomas St
Ultimo NSW 2007
Country 118507 0
Australia
Phone 118507 0
+61423813185
Fax 118507 0
Email 118507 0
[email protected]
Contact person for scientific queries
Name 118508 0
Parisa Noorian
Address 118508 0
Dr Parisa Noorian
UTS Science Store
Building 1, Level 2, Thomas St
Ultimo NSW 2007
Country 118508 0
Australia
Phone 118508 0
+61423813185
Fax 118508 0
Email 118508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.