Prevention of UTI in Persons With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 10
- 主要终点
- Putting E. coli 83972 into the bladder of SCI patients reduces the rate of symptomatic UTI.
研究概览
简要总结
Urinary tract infection (UTI) is the most common infection in patients with spinal cord injury (SCI) and is linked to major undesired results or complications including death. The bladder of SCI patients, especially those with indwelling catheters, is usually colonized by bacteria, some of which do and others which do not cause symptoms of UTI. Bacteria that do not cause symptoms are often called benign colonizers and are often left untreated because they may provide some protection against infection with more harmful bacteria. This idea of using benign bacteria to prevent infections with symptoms is called bacterial interference. A prototype strain, Escherichia coli 83972, was shown to begin and continue for extended periods of time non symptom causing colonization of the human bladder and to hold back symptom causing infections of the neurogenic bladder. Data from pilot studies at two medical centers indicated that bacterial interference might be a useful therapy for reducing the rate or frequency of UTI in SCI patients. Because almost all SCI patients have a UTI at some time, and also the large costs of treating this infection, studying the impact of bladder colonization with E. coli 83972 on the rate of symptom causing UTI has an amazing potential for improving the quality of life of SCI patients and decreasing the cost of health care. Like with other preventive plans such as vaccination, for instance, it is important to explore the effectiveness of this new preventive approach. The project is a prospective, randomized, double blind, multi-center study that deals with specific pieces of bacterial interference in SCI patients.
HYPOTHESES: Placing non symptom causing bacteria (E. coli 83972) into SCI patients' bladders reduces the rate of symptom causing UTI.
A. SPECIFIC AIM: Determine how bladder colonization with E. coli 83972 or similar bacteria affects the rate of symptom causing urinary tract infections in a large group of SCI and Spina Bifida patients by conducting a prospective, randomized, placebo-controlled, multi-center clinical trial.
详细描述
This clinical trial will be take place in a total of 7 medical centers that care for Spinal cord injury (SCI) and Spina Bifida patients. A total of 160 patients will be allowed to take part in the study.
The study coordinator will interview patients by telephone and in person who express an interest in taking part in the study. After an informed consent and HIPAA documents are reviewed and all of the patients questions are answered, then they will be asked to sign these two forms. Then a code number will be assigned to each patient and used along with their initials to identify them for the remainder of the study. All study participants will have a complete history and physical examination including ASIA classification, serum creatinine and a urine culture immediately upon entry into the study. One of the following 3 diagnostic tests must be completed within the 3 months before the study: KUB, IVP, or non-contrast abdominal CT scan. A voiding cystourethrogram with fluoroscopy (VCUG) alone or as part of a video urodynamics evaluation must be completed within 1 year before the study.
Randomization and sample size: Enrolled subjects will be randomized in a 3:1 ratio to receive bladder inoculation either with E. coli 83972 (experimental group) or with placebo (control group). This randomization ratio was selected because around 1/3 of colonized subjects are expected to remain colonized for 12 months.
Bladder inoculation: At study entry, a urine culture and sensitivity test will be completed using a fresh mid stream (after the urine is flowing) urine sample removed via a catheter into the bladder. Subjects will stop all actions to prevent or slow urinary tract infection (UTI) for at least two weeks upon entry into the study. Each subject will be treated with correct antibiotics for 7 - 10 days and any existing urinary catheter changed three days after starting antibiotic treatment. Forty-eight to 72 hours or (80 to 90 hours for fluoroquinolone antibiotics) after completion of antibiotics, the urine will be re-cultured and the lower urinary tract inoculated with E. coli 83972 or placebo.
Most subjects, even those with external condom catheters, have worn a Foley catheter at some time, and would be expected to know the catheter size that best fits them. Subjects will be inoculated on three consecutive days. Inoculation will consist of putting into the bladder via a sterile catheter 10 ml of normal saline alone or containing E. coli 83972. Subjects who are incontinent at low bladder volumes will be monitored with a Foley catheter balloon blocking the bladder neck or diversion stoma for 30 minutes after inoculation. After 30 min., the clamp will be released and the bladder allowed to drain for an additional 30 min. The bladder inoculation will be repeated a second time unless an unexpected adverse event (complication) is encountered. After the catheter is un-clamped for the second time, the subject will be observed for 30 min. before discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 15 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15 years or older
- •Living in institutional or non-institutional settings
- •6 months post spinal cord injury (SCI) prior to entry or have Spina Bifida
- •Loss of bladder function
- •Loss of normal bladder sensation
- •Selected in-patients involved in the Rehab I program
- •Catheter dependent, having either an indwelling urinary catheter or using an external catheter, intermittent catheterization, or vesical urinary diversion (original bladder, whole or in part, serves as the collection receptacle for urine) for bladder management.
- •Two or more urinary tract infections (UTI) within the 12 months prior to the study.
- •Capable of understanding the purpose of the study and providing informed consent to participate
- •Pursue appropriate follow-up over the course of the study.
排除标准
- •Any bladder stone(s)
- •Kidney stone(s) greater than 1 cm in size
- •Any obstructing kidney stone regardless of size
- •Nephrostomy tube(s)
- •Supravesical diversion (original bladder is no longer part of the collection receptacle for urine)
- •Congenital genitourinary anomaly that predisposes to UTI
- •Conditions anticipated to require recurrent antibiotic therapy for extraurogenital infection (e.g., recurrent pneumonia, decubitus ulcer)
- •Current immunosuppression
- •Vascular prosthesis
- •Congenital or acquired cardiac disease susceptible to vegetative infections
- •Bladder capacity of less than 50 cc
- •Individuals with known significant cognitive impairment resulting from trauma, disease, or congenital conditions
- •Women of childbearing age who engage in unprotected intercourse
- •Women who are currently pregnant will be included in the study
- •Women who become pregnant during the study will be discontinued from participation. Pregnant women who experience UTI or prolonged asymptomatic bacteriuria are at risk of bearing infants with low birth weight.
- •Prisoners
- •Men and women with significant known mental illness or emotional disorders related to organic or inorganic causes.
结局指标
主要结局
Putting E. coli 83972 into the bladder of SCI patients reduces the rate of symptomatic UTI.
时间窗: 12 Months
次要结局
- Study the affect of bladder colonization with E. coli 83972 on the rate of symptom causing UTI in a large group of SCI and Spina Bifida patients.(12 Months)
研究者
Rabih Darouiche
Principal Investigator
Baylor College of Medicine