Metagenomics-based diagnostics for the prediction, prognosis and prevention of urinary tract infections in patients who use catheters for bladder management

niversity of Technology Sydney0 个研究点目标入组 60 人开始时间: 2022年4月26日最近更新: 2023年4月10日

试验速览

暂无简介。

•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.

•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).

发起方

niversity of Technology Sydney