UTI Prophylaxis Using Bacterial Interference Following SCI
Urinary tract infection (UTI) is the most common infection in patients with SCI and is a major cause of morbidity and mortality in this population. The bladder of patients with SCI, especially those who have indwelling catheters, is often colonized by bacteria that may or may not cause symptoms of UTI. Bacteria that do not cause symptoms are usually considered benign colonizers and are often left untreated because they may afford some protection against symptomatic infection with more harmful bacteria.
We applied the concept of using benign bacteria to prevent symptomatic infection, so-called bacterial interference, by deliberately colonizing the bladder of patients with SCI with a non-pathogenic prototype of Escherichia coli (strain 83972). The preliminary results of our VA-funded study that compared the rates of symptomatic UTI in patients with SCI while colonized with E. coli 83972 vs. historical rates of symptomatic UTI prior to study enrollment indicated that deliberate colonization of the bladder of patients with SCI with E. coli 83972 is safe and very promising as to its ability to prevent symptomatic UTI. However, before this innovative approach of bacterial interference can be successfully applied in the population of patients with SCI, it is essential to: (A) confirm the ultimate efficacy of bacterial interference by conducting a prospective, randomized, placebo-controlled clinical trial (objective #1); and (B) enhance the practicality of applying this innovative approach in SCI patients by delineating the bacterial and host factors that can promote successful colonization with E. coli 83972 (objectives #2-3).
A prospective, randomized, placebo-controlled clinical trial will be conducted. Patients who had sustained SCI >18 months earlier, suffer from neurogenic bladder (require intermittent bladder catheterization, an indwelling suprapubic catheter, or an external collection device), and have a history of frequent symptomatic UTI (> 2 episodes during the preceding year) will be eligible for enrollment. Exclusion criteria will include urolithiasis, indwelling nephrostomy catheter, indwelling transurethral foley catheter, supravesical urinary diversion, vesicoureteral reflux, conditions anticipated to require antibiotic therapy for chronic recurrent extraurogenital infections (e.g. infected decubitus ulcers), uncontrolled diabetes mellitus and immunosuppression. Patients considered unreliable to pursue adequate follow-up and those incapable of giving informed consent will also be excluded. Subjects will discontinue all measures to suppress UTI for at least two weeks prior to entry into the study. All patients will have a complete history and physical examination, serum creatinine, plain X-ray of the abdomen (KUB), and urine culture immediately prior to entry into the study. Renal ultrasound and urodynamic evaluation of the urinary tract will also be obtained upon study entry unless they have been performed during the preceding year.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
Urinary Tract Infections
Michael E. DeBakey VA Medical Center (152)
Department of Veterans Affairs
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00037921
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Urinary Tract Infections
Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.
A surgical specialty concerned with the study, diagnosis, and treatment of diseases of the urinary tract in both sexes, and the genital tract in the male. Common urological problems include urinary obstruction, URINARY INCONTINENCE, infections, and UROGENITAL NEOPLASMS.
A second-generation cephalosporin administered intravenously or intramuscularly. Its bactericidal action results from inhibition of cell wall synthesis. It is used for urinary tract infections, lower respiratory tract infections, and soft tissue and bone infections.
The presence of white blood cells (LEUKOCYTES) in the urine. It is often associated with bacterial infections of the urinary tract. Pyuria without BACTERIURIA can be caused by TUBERCULOSIS, stones, or cancer.
Uropathogenic Escherichia Coli
Strains of Escherichia coli that preferentially grow and persist within the urinary tract. They exhibit certain virulence factors and strategies that cause urinary tract infections.
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...
To investigate if administration of probiotics, either orally or vaginally, - Can reduce the number of episodes of acute bacterial cystitis and/or - Has tolerable adverse effect pr...
Recurrent urinary tract infections (RUTIS) continue to be a major health problem in women and are now complicated by increasing antibiotic resistance. New preventive approaches are needed....
The purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an antibiotic) with that of oral lomefloxacin in the treatment of complicated urinary tract infect...
The purpose of this study is determine whether a vaginal mucosal vaccine given to women with a history of recurrent urinary tract infections can reduce the number of infections occurring i...
Recurrent urinary tract infections, presenting as dysuria or irritative voiding symptoms, are most commonly caused by reinfection with the original bacterial isolate in young, otherwise healthy women...
Urinary tract infections occur very frequently in the community and in hospitalized patients and are mainly caused by Escherichia (E.) coli. Depending on virulence determinants of uropathogenic microo...
Most (59% to 86%) hospital-acquired urinary tract infections (UTIs) are catheter-associated urinary tract infections (CAUTIs). As of 2008, claims data are used to deny payment for certain hospital-acq...
Establishment of asymptomatic bacteriuria (ABU) with Escherichia coli 83972 is a viable prophylactic alternative to antibiotic therapy for the prevention of recurrent bacterial urinary tract infection...
PURPOSE: Urinary tract infection will develop in 40% of children who undergo renal transplantation. Post-transplant urinary tract infection is associated with earlier graft loss in adults. However, th...