23 Clinical Trials for Various Conditions
This is a Phase 1b study to assess the safety, tolerability, PK, and PD of investigational phage therapy (IP) in adults with SCI and bladder colonization (ASB). It is a single-center, randomized, double-blind, placebo-controlled study in adults with SCI with neurogenic bladders and bacteriuria who use indwelling catheters, or who require intermittent catheterization for bladder drainage.
This is a prospective randomized controlled trial to look into the reduction of catheter associated urinary tract infections in the postoperative period. It will specifically look at short gynecologic procedures such as D\&C (dilation and curettage), hysteroscopies and LEEP procedures and the need to perform intraoperative catheterization. If a patient urinates immediately before a short operation then there is no need to drain the bladder with a catheter during the procedure. The investigators hypothesize that eliminating catheterization during these short procedures may decrease postoperative urinary tract infections. The hope is that this study would provide evidence to support a change in practice.
The goal of this research program is to understand the natural history of asymptomatic bacteriuria in the renal transplant patients, to determine if screening for asymptomatic bacteriuria and identification of key host characteristics and virulence factors present on uropathogenic bacteria identifies a sub-population of patients with asymptomatic bacteriuria that are at risk to develop symptomatic urinary tract infection. Ultimately, the knowledge obtained from this study will prevent inappropriate antibiotic use and may identify whether certain bacterial isolates predispose to renal allograft injury. We will test the hypothesis that (i) asymptomatic bacteriuria is common in the renal allograft recipient and (ii) that symptomatic urinary tract infection and renal allograft dysfunction do not occur unless key host susceptibility factors and uropathogenic bacterial virulence factors are present.
Overtreatment of asymptomatic bacteriuria (ABU) is a quality, safety, and cost issue, particularly as unnecessary antibiotics lead to emergence of resistant pathogens. The investigators' proposal to bring clinical practice in line with published guidelines has significant potential to reduce unnecessary antibiotic use for ABU in the VA healthcare system, thus improving the quality and safety of veterans' healthcare. The investigators' study will also provide important insights about how to implement and sustain evidence-based clinical practice within VA hospitals.
This study will investigate whether there is a particular dose of cranberry capsules that is effective in preventing the occurrence of urinary tract infections in females at least 65 years of age or older who live in a nursing home and who have a history of urinary tract infections. The Yale research team will be enrolling 80 subjects in total over several nursing home locations within Connecticut.
The purpose of this clinical trial is to study the effects of NVC-422 instilled into the bladder in reducing bacteria in the urine.
Many children who catheterize their bladders because of spina bifida or other neurologic disorders have bacteriuria. This can lead to urinary tract infections by bacteria from the gut which colonize the vagina and are carried into the bladder during catheter passage. We seek to test whether oral administration of probiotic bacteria can "displace" these vagina-derived uropathogens and reduce or prevent bacteriuria in girls with spina bifida who empty their bladders through catheterization.
The purpose of the study is to determine if treatment of pregnant women with urine cultures with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease adverse pregnancy outcomes.
This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Urine and/or catheter DNA analysis will be obtained at catheter insertion, 2, 5, 7 and 14 days after catheterization.
This is a prospective randomized controlled day comparing the efficacy of three-day antimicrobial treatment of asymptomatic bacteriuria (ASB) in pregnancy to the standard seven-day treatment. Half the patients will receive 3-day treatment and the other half will receive 7 days of antibiotics.
The purpose of this research study is to compare the effectiveness and efficiency of using a sterile sheath (EndoSheath®) during cystoscopy versus a standard scope.
Urinary tract infection (UTI) is the most common infection in nursing home residents, and bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting. The primary aim of this study is to test the efficacy of two oral cranberry capsules per day in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will be accomplished by conducting a double blind randomized placebo controlled efficacy trial of two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing home residents.
This study aims specifically to compare the rates of contaminants between standard clean-catch urine collection and urine collected using the PEEZY device. In particular, this study will compare the rates of contamination as stratified by BMI status (i.e., BMI \< 30 and BMI ≥30). Based on previous studies through LUHS and the Wolfe lab, we anticipate a reduction in contamination from sample collected using the PEEZY device, particularly among those pregnant women with BMI ≥30. To investigate this hypothesis we have designed a prospective unblinded randomized controlled trial comparing voided urine specimens obtained for asymptomatic bacteriuria in pregnant women presenting for obstetric care with use of standard clean-catch (CC) sampling method versus specimen obtained using PEEZY collection device.
This is a prospective, observational study assessing the results of urine dipsticks on adult volunteers with no acute symptoms. We seek to determine the frequency of leukocytes or nitrites in this group of individuals.
This study is to help determine if drinking cranberry juice can decrease risk for asymptomatic bacteriuria (ASB). ASB occurs when there are bacteria in the urine without any symptoms. It will also see if there is a difference in this effect between pregnant and non-pregnant women.This research project is also designed to see what happens to bacterial binding to the lining of the bladder after drinking cranberry juice when special problems occur with pregnancy such as diabetes (a sugar metabolism problem) or ASB is already occurring.
The purpose of this study is to find the best cleaning and collection methods to obtain a 'non-contaminated' clean catch mid-stream urine sample to diagnose suspected urinary tract infection (UTI).
The purpose of this study is to determine the amount of cranberry juice that is most effective in preventing a condition in pregnant women that often leads to urinary tract infections (UTIs).
Investigators will evaluate clinical decision support nudges informed by behavioral science and directed at primary care clinicians. These will be used to reduce commonly misused, and potentially harmful, diagnostic and therapeutic actions that occur in the care of older adults (e.g. overtreatment of type 2 diabetes, misuse of PSA screening, misuse of urine testing in women with nonspecific symptoms or no symptoms.
The risks and benefits of many diagnostic approaches and treatments differ for older adults compared to middle aged adults. When diagnostic and therapeutic strategies are misapplied to older adults this can lead to increased morbidity and mortality. Well established examples where clinicians do not often follow best practices in the care of older adults include those identified by the American Geriatrics Society for the Choosing Wisely initiative: 1) testing and treatment for asymptomatic bacteriuria, 2) prostate specific antigen testing in older men without prostate cancer, and 3) overuse of insulin or oral hypoglycemics for type 2 diabetes. Clinical decision support nudges, informed by social psychology and delivered via electronic health records (EHRs), are promising strategies to reduce the misuse of services in cases where optimal utilization may not be zero but should be well below current practice. These interventions seek to influence conscious and unconscious drivers of clinical decision making, are low cost to implement and disseminate, and can be incorporated into existing delivery systems. In the R21 phase of this Behavioral Economics Applications to Geriatrics Leveraging EHRs (BEAGLE) study, we will: select EHR delivered nudges to address 3 topics of potential misuse in older adults based on the main psychological drivers of overuse identified in interviews with high-using clinicians; develop and pilot test decision support tools within a health systems' EHR to understand technical feasibility, work flow fit, preliminary impact on clinical outcomes, and clinician acceptability; and develop and validate electronic clinical quality measures of potential overuse/misuse related to the care of older adults.
The purpose of this study is to determine if the study Foley catheter with its patterned external surface can delay the time to the onset of urinary tract infection in spinal cord injury patients who are dependent on a Foley catheter for drainage of their urinary bladder.
The investigators hypothesize that many parturients can, in fact, spontaneously micturate with low dose combined spinal epidural analgesic doses given for labor and that Foley catheterization is unnecessary in the majority of these parturients. At Prentice Women's Hospital, almost 9000 women annually receive neuraxial labor analgesia and 98% of those receive Foley catheters. By potentially reducing the necessity for Foley catheters, the investigators should be able to ultimately reduce the rate of bacteriuria, urinary tract infections and urethritis leading to unnecessary treatment with antibiotics, as well as reduce costs of placing unnecessary Foley catheter.The hypothesis is parturients receiving low dose combined spinal epidural analgesia for analgesia after induction of labor who are randomized to a spontaneous micturition protocol will require fewer Foley catheter placements and demonstrate a lower incidence of positive urine culture postpartum than those who undergo standard Foley catheter placement.
Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studies using adults over the last 30 years. Very few studies have been conducted with children. UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and peri-urethral mucosa, thus gaining access to the bladder. This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics + placebo) to determine if UTIs are decreased when the probiotics are given.
Girls with spina bifida also have bladder problems. This is because they need temporary placement of a tube into the bladder to remove urine. This thin flexible tube is called a catheter. It can increase the risk of having bacteria in the urine. This in turn can lead to urinary tract infection (UTI). Some girls with spina bifida are given antibiotics. These are medicines used to treat infections caused by bacteria. The medicine is used to prevent UTI. However, long-term treatment with these medicines can have side effects. For example, the bacteria may become resistant to the antibiotics. Also, bacteria in the urine can persist. UTI can still occur in patients on antibiotics. UTI in girls occurs because bacteria migrate from the rectum to the vagina area. This gives the bacteria access to the bladder. Also, in girls with spina bifida, the access to the bladder is easier because of the catheter. Probiotics are friendly bacteria. They are available as dietary supplements and as food. They contain helpful bacteria. Yogurt is an example of a food that contains probiotics. The purpose of this study is to find out, if probiotics taken for 6 months can prevent UTI in girls with spina bifida. We will also try to find out whether changes in urine bacteria are associated with the taking of the probiotics. A vaginal and rectal swab will also be done to find out if taking probiotics has any benefits on preventing bacteria.