None listed
Conditions
Brief summary
Spinal cord injury patients are at high risk of catheter associated urinary tract infections (CAUTI), including infection by multidrug resistant organisms. This has severe consequences for their quality of life, including life threatening infections. Such infections also represent a significant cost to hospitals and a source of drug resistant organisms that can spread throughout hospitals. Overall, this project aims to develop diagnostic technologies to facilitate treatment decisions before full-blown symptoms appear as well as evaluate intervention strategies to expand options for how to protect this high risk patient population including the use of non drug based approaches. This projects plans to develop a new catheter coating that could be used in high risk patients. The benefits would be improved quality of life, reduced moralities, reduced spread of drug resistant bacteria and significant cost savings to hospitals. A key issue is that physicians do not act until a UTI is diagnosed. Part of the solution would be better monitoring of patients to predict when they are at increased risk of CAUTIs. A predictive diagnostic would enable physicians to intervene earlier and to employ a wider range of strategies, rather than relying solely on the use of antibiotics. This project will expand on our preliminary data and develop a robust, simpler and cheaper methodology to monitor the microbial community for changes in composition. This would represent an early warning that the patient may be moving towards an infected status. The project will also develop a mixed species biofilm system for laboratory evaluation of interventions aimed at controlling or eradicating biofilms on catheters. We will further use this laboratory system to investigate the mechanisms used by pathogenic bacteria to invade otherwise nonpathogenic microbial communities to cause infections. This will lead to new strategies for infection control.
Interventions
-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 participa
-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.
Sponsors
University of Technology Sydney
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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).
Outcome results
None listed