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Asymptomatic Bacteriuria clinical trials

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NCT ID: NCT04333602 Completed - Clinical trials for Kidney Transplant Infection

Asymptomatic Bacteriuria in Early Kidney Transplantation Follow up

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Urinary tract infection (UTI) continues to be the leading cause of infection and hospitalization in post-kidney transplant (RT) surveillance. Facts such as immunosuppression, anatomical alterations and catheters are part of the factors that contribute to a high prevalence of this condition. The incidence during the first trimester is highly variable and ranges between 15 and 50 %. This variability often depends on the definition of UTI, which sometimes overlaps with asymptomatic bacteriuria (AB). Currently the indication for treatment of AB is clear in pregnant patients and urological procedures. In post-RT surveillance, the treatment of AB is controversial. The use of Trimetropim Sulfamethoxazole during the first 6 months post RT is currently a recommendation, however new evidence has found the absence of benefit in the treatment of AB. Given the high prevalence of post RT AB and the increase in bacterial resistance, determining the usefulness of searching for and treating post RT AB is a priority in this population. Methodology: Randomized Controlled trial of kidney transplant candidates which will be randomized in the following groups: Group 1 (intervention) where the urine cultures will be analyzed openly, and in the case of asymptomatic bacteriuria, treatment based on the germ and antibiogram will be prescribed. Group 2 will undergo urine cultures at the same post-transplant times, the results will not be known by the clinical team and the participants will not receive treatment in the presence of present AB. Both groups, in the presence of UTI symptoms, will undergo urine culture and receive empirical treatment, which will be adjusted based on an antibiogram. The primary objective is to assess the prevalence of UTI, pyelonephritis, UTI-related hospitalizations, and antimicrobial resistance. As a secondary objective, the germs and associated virulence genes will be analyzed. Surveillance will be carried out for two months after transplantation and the predefined times for the evaluation of the BA will be: after the removal of the urinary catheter, week 3 and after the removal of the ureteral stent (month 2).

NCT ID: NCT04289753 Completed - Type 2 Diabetes Clinical Trials

Behavioral Economics Applications to Geriatrics Leveraging EHRs R33 Trial

BEAGLE R33
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04055675 Completed - Clinical trials for Asymptomatic Bacteriuria

Urinalysis Results in Healthy Individuals

Start date: July 3, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT03704389 Completed - Clinical trials for Type 2 Diabetes Mellitus

Behavioral Economics Applications to Geriatrics Leveraging EHRs

BEAGLE R21
Start date: January 17, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03554603 Completed - Clinical trials for Urinary Tract Infections

Modified Reporting of Positive Urine Cultures Collected From Long Term Care

Start date: November 5, 2018
Phase: N/A
Study type: Interventional

Asymptomatic bacteriuria (AB) is a condition in which bacteria are detected in urine culture without urinary symptoms. The inappropriate use of antibiotic treatment for AB selects bacterial flora to express resistance mutations. Reducing inappropriate antibiotic use for AB is difficult, since the microbiology laboratory cannot distinguish patients with AB. The investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. The restricted report may reduce the rate of inappropriate treatment of AB.

NCT ID: NCT03445312 Completed - Clinical trials for Urinary Tract Infections

Safety and Effectiveness of a Laboratory Intervention to Effectively NOT Treat Asymptomatic Bacteriuria

Salient
Start date: August 31, 2017
Phase:
Study type: Observational

This is an observational cohort study of 1000 consecutive patients on medical and surgical wards at the Mount Sinai Hospital in Toronto who have a mid-stream urine culture ordered. When these cultures are ordered or received in the laboratory, a message is posted that the specimen will not be processed in the laboratory unless a call is received to say that the patient has local urinary symptoms. The goal is to establish whether not processing mid-stream urine cultures is safe.

NCT ID: NCT03235947 Completed - Clinical trials for Urinary Tract Infection

Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients

PERIFOS
Start date: September 7, 2016
Phase: Phase 4
Study type: Interventional

A clinical controlled, randomized and double blind trial that included adult patients (≥18 years) receiving kidney transplantation (KT) at the INCMNSZ. The intervention group will receive disodium fosfomycin 4 g intravenously in three moments: preoperative of transplant surgery, prior to removal of the urinary catheter and finally prior to removal of ureteral catheter. The control group will receive placebo in the same moments. Both groups will receive prophylaxis standard for urinary tract infection (UTI), with trimethoprim/sulfamethoxazole 160/800 mg per day. This prophylaxis will be administered once the estimated glomerular filtration rate is greater than 30 mL/min/1.73m2. The primary objective is to compare the average number of episodes of UTI´s and asymptomatic bacteriuria in both groups after 7 weeks of follow-up. The secondary objectives are to know the incidence of asymptomatic bacteriuria, the incidence of hospitalizations for IVU, the days of hospital stay, the pattern of bacterial resistance, the safety of disodium fosfomycin, and assessment of the function of the graft and rejection rate.

NCT ID: NCT02373085 Completed - Clinical trials for Asymptomatic Bacteriuria

Prospective Comparative Study About Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients.

Start date: January 2011
Phase: N/A
Study type: Interventional

Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.

NCT ID: NCT01871753 Completed - Clinical trials for Kidney Transplantation

The Bacteriuria in Renal Transplantation (BiRT) Study: A Trial Comparing Antibiotics Versus no Treatment in the Prevention of Symptomatic Urinary Tract Infection in Kidney Transplant Recipients With Asymptomatic Bacteriuria

BiRT
Start date: April 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria.

NCT ID: NCT01820897 Completed - Clinical trials for Urinary Tract Infection

Efficacy of Fosfomycin-Trometamol in Urinary Tract Infection Prophylaxis After Kidney Transplantation

Start date: April 2013
Phase: Phase 4
Study type: Interventional

Urinary tract infections (UTI) are the most common complications after kidney transplantation. Most series have reported incidence between 20 to 50% during the first year. In the most recent report from our center the incidence was 36.6% during the first 6 months after transplantation. The clinical consequence in the graft survival and the association with immunological rejection has not been well defined. Nevertheless, the association of UTI with high rate of hospitalization and their costs are widely recognized. There is paucity of trials, specially randomized and controlled, comparing antibiotic prophylaxis in this group of patients. In a recently published metaanalysis Green et al. (Transpl Infect Dis. 2011 Oct;13(5):441-7) found only 6 clinical trials well designed, the conclusion was that antibiotic prophylaxis reduced the incidence of UTI and the risk of sepsis. Based in this information, the KDIGO guidelines in transplantation recommend the prophylaxis for UTI with sulfamethoxazole-trimethoprim (SMT). Nevertheless, the rate of bacterial resistance to SMT has been reported above 50% in almost all the series. Fosfomycin-trometamol (FT) is a wall antibiotic (piruvil-tranferase inhibitor) that has shown a good bioavailability, especially in the urinary tract. It has shown a wide antibacterial spectrum, but the important target seems to be enteric bacilli particularly Escherichia coli (the most prevalent cause of UTI). FT has also shown a very good activity against E. coli producer of Extended Spectrum Betalactamases. Recently, the rate of these multi-drug resistant bacteria has increased in our center as evidence of worldwide distribution. In addition, the rate of FT resistance has been stable during the last years (<3%). This phenomenon could be explained because of the properties of this antibiotic, the most important one seems to be related with the unique mechanism of action and the lack to propagate the mechanisms of resistance at least in E. coli. There is only one clinical trial (randomized and controlled), which compared FT with placebo in UTI prophylaxis; 317 women with recurrent UTI (three by year) were included. They found rates of 0.14 and 2.9 episodes/patient/year, respectively (p<0.001). Furthermore, there was no FT resistance during the follow up. Our hypothesis is that in the first six months after kidney transplantation, UTI prophylaxis with FT will show greater efficacy in comparison with SMT. Considering the incidence of UTI in our center (36.6%) and the rate of UTI in the unique trial of prophylaxis with FT (14%), 65 patients will be needed by group of treatment to demonstrate a difference of 22% in the incidence of UTI, with a power of 80% and confidence level of 95%. The primary outcome is the incidence and rate of UTI during the first six months after kidney transplantation. The secondary outcomes are, the hospitalization rate, antibiotic resistance rate, rejections and titer and number of de novo donor specific antibodies. The investigators propose a randomized, double blind, placebo controlled trial to compare FT with SMT in the efficacy and safety to prevent UTI during the first six months after kidney transplantation. The investigators will include patients from two tertiary-care transplant centers. Recruiting and the randomization will be carried out separately by center and gender (because female patients have a greater risk of UTI). The medical visits will be scheduled monthly and include general laboratory, urine culture and information gathering about antibiotic side effects as well as adherence. Rejection rate and the number and titers of de novo donor specific antibodies (secondary outcome) will be obtained according to the standard of care of the institutional kidney transplantation follow up. These include kidney biopsy at days 0 and 90 after transplantation, as well as determination of donor specific antibodies after sixth months of follow up. Graft biopsy is also performed whenever graft dysfunction exists in the absence of an identifiable cause (infection, urinary graft obstruction).