Clinical Research Directory

The Application of a Novel Urinalysis System (UF-5000) for Reducing Unnecessary Antibiotic Use in Clinical Suspected UTI Patients

Urinary tract infection (UTI) is one of the most common diseases in the population, while antibiotic resistance in UTI has become a critical problem in Hong Kong, with a large proportion of bacteria causing UTI resistant to commonly used anti-UTI antibiotic treatments. This resistance is largely due to empirical treatment (i.e. no bacterial information is available at the time of treatment) and antibiotic overtreatment over the past decades. Some patients without UTI were prescribed antibiotics because of symptoms similar to UTI. To avoid unnecessary antibiotic use and therefore reduce antibiotic resistance rates in UTI, the investigators propose to apply a new urine sediment analyzer (UF-5000) in clinical practice for UTI. The analyzer could provide rapid identification of potential bacteria in urine and more information on possible bacterial species. UF-5000 is a urine sediment analyzer manufactured by Sysmex Ltd. (Japan). The analyzer is widely used in hospital central laboratories and private laboratories but is not commonly seen in outpatient clinic settings. UF-5000 is capable of counting bacteria present in a urine sample and providing Gram staining results within 5 minutes, while routine urine culture takes around 3 days. A study conducted by The University of Hong Kong in 2019 showed that UF-5000 has higher accuracy than conventional dipstick testing, with reliable Gram staining results. The analyzer has a negative predictive value of 96%, indicating a high likelihood that a negative result corresponds to the absence of UTI. Cases with symptoms similar to UTI were mostly inflammatory diseases without a need for antibiotics. This study aims to evaluate whether bacterial information provided by UF-5000 can guide precise antibiotic treatment and avoid unnecessary antibiotic use.

Chlorhexidine Lavage for Recurrent Urinary Tract Infection

A two-arm randomized control trial evaluating rates of urinary tract infection in post-menopausal women on vaginal estrogen with recurrent urinary tract infections.

Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)

The aim is to identify genomic determinants (genes or gene clusters) associated with the severity of community-acquired E. coli urinary tract infections in Guadeloupe through a comparative approach integrating clinical, microbiological, and genomic data (GWAS approach).

Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections

The objectives are to evaluate whether variations in vaginal and/or urinary and/or fecal microbiome predispose postmenopausal women to recurrent cystitis. This will be explored using comparison of microbiome profiles between those with recurrent UTI compared to age-matched women without recurrent UTI.

Prophylactic Antibiotics for Outpatient Urethral Bulking

The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).

The Impact of De-implementing Urine Dipsticks for Diagnosis of UTIs in Hospitals

The goal of this interrupted time-series analysis is to evaluate the impact of the de-implementation of urine dipsticks as a diagnostic tool for urinary tract infections (UTIs) in hospitalized patients in the North Denmark Region. The main question it aims to answer is: How does de-implementation of urine dipsticks affect the diagnosis and management of UTIs and related disorders? Specifically, does it change the following parameters: * Number and severity of UTI infections (lower and upper UTI, non-severe and severe) * Antibiotic prescription (overall, antibiotic classes, administration routes, duration, dosages) * Number of urine cultures and number of positive urine cultures * Risks of admission to intensive care units and 30-day mortality * Risk of drug toxicity * Length of hospital stay * Risk of admission to intensive care unit * 30-day risk of readmission after discharge * 6-month risks of Clostridioides difficile enterocolitis and de novo antimicrobial resistance in cultures obtained during routine clinical care. Researchers hypothesize that de-implementing urine dipsticks will lead to a reduced frequency of diagnosed cystitis, reduced antibiotic use, and fewer urine cultures without negatively affecting patient mortality or readmission risk. Researchers will compare the outcomes before and after the discontinuation of urine dipsticks across hospitals in the North Denmark Region. Furthermore, results will be compared to another Danish administrative healthcare region where dipsticks are still in use as well as urine culture data from the primary sector in the North Denmark Region. Since this is a registry-based observational study utilizing data from the electronic patient record system in the North Denmark Region, no direct contact will be made with participants.

VA Quality Enhancement Research Initiative (QUERI) CARRIAGE VAST

Antimicrobial-resistant and healthcare-associated pathogens are a global health threat. The goals of antimicrobial stewardship are to minimize unnecessary and inappropriate antimicrobial use as a means to combat antimicrobial resistance. The interdisciplinary Videoconference Antimicrobial Stewardship Team (VAST) was initially developed and tested as a telehealth teleconferencing training and mentoring program in 2 rural pilot sites, then was extended to 9 rural sites, using telehealth to connect clinicians at a rural VAMC to a geographically distant infectious disease expert. Qualitative interviews showed that participants valued VAST and it improved patient care. This project will expand the VAST to other VAMCs and assess the VASTs' impact on antimicrobial prescribing. This work will directly increase access to antimicrobial stewardship consultation at rural VA facilities, which are often underserved by infectious disease expertise.

Discharge Stewardship in Children's Hospitals

The goal of this interventional study is to test if a discharge stewardship bundle is effective at reducing inappropriate antibiotic prescriptions at hospital discharge for children with the three common infections: community-acquired pneumonia (CAP), urinary tract infections (UTI), and skin/soft tissue infections (SSTI). The goals of this study are: * To develop, locally adapt, and implement a discharge stewardship intervention across four geographically diverse children's hospitals. * To measure the impact of the discharge stewardship intervention on antibiotic prescribing and patient outcome for three common pediatric infections. Families who are enrolled in the study will be asked to: * complete a one question wellness track on days 3, 7, and 21 after hospital discharge * complete a brief survey on days 7 and 21 after hospital discharge The study team will conduct interviews with the hospitalists at each of the four participating hospitals to create a "discharge stewardship" bundle. Once the bundle intervention is implemented, the hospitalists will be asked to follow prescribing guidelines for CAP, UTI, and SSTI. They will receive regular group-level feedback reports to show how well they follow the guidelines and motivate the hospitalists to follow the guidelines better.

A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women

This study aims to evaluate the pharmacokinetic of gepotidacin in fed healthy lactating women.

A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics

The study will be conducted to evaluate how a single oral dose of Gepotidacin is processed in the body over time along with safety monitoring in hospitalized pediatric participants who are receiving a standard of care treatment with antibacterials for a confirmed or suspected infection or for its prevention.

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

This is a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 288 patient blinded portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline.

WMT for Multidrug-Resistant Organism UTI

This is a single-center, prospective, single-arm, exploratory clinical study to evaluate the efficacy, safety, and potential mechanisms of washed microbiota transplantation (WMT) in patients with recurrent urinary tract infections caused by multidrug-resistant organisms (MDRO-UTI). With increasing antimicrobial resistance, MDRO UTI becomes refractory and poses a significant therapeutic challenge. WMT may reconstruct gut microbiota, reduce uropathogen colonization, decrease antibiotic resistance gene burden, and modulate host immunity and metabolism. Approximately 10 eligible patients will receive WMT delivered via colonic transendoscopic enteral tubing (TET) for 3 times according to the Nanjing Consensus on Washed Microbiota Transplantation. Participants will be followed for up to 12 months with clinical, microbiological, metagenomic, metabolomic, and immunological assessments.

Qualitative Assessment of the Impact of TTNS on QOL and Participation

This study through the use of semi-structured interviews or focus groups will explore the lived experience with Transcutaneous Tibial Nerve Stimulation (TTNS) with Neurogenic Lower Urinary Tract Dysfunction to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.

Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study

The purpose of this study is to determine if a single dose of amikacin (a type of antibiotic) can be used to effectively treat emergency department patients with uncomplicated cystitis (inflammation of the bladder). Participating in this study will allow the patient to treat their urinary tract infection (UTI) with a single intramuscular (IM (into the arm)) or intravenous (IV (into the vein)) shot of amikacin, rather than having to go to the pharmacy to pick up a prescription for antibiotics, and then take antibiotics for 3-7 days. A single dose of amikacin has been demonstrated to be safe, effective and well tolerated in other studies, but some patients may decline to participate because they do not wish to have an IV or IM shot, or because they don't want to speak on the phone with a research assistant three times over the next 30 days.

POS-cUTI: Study on Complicated Urinary Tract Infections

Urinary tract infections (UTI) are among the most common infectious diseases and the most frequent source of community, healthcare-associated and nosocomial bacteraemia. They are associated with significant morbidity and mortality. Due to the high frequency of UTI, they have a major impact on antibiotic use and the antimicrobial resistance of prominent UTI pathogens is of recognised importance. Therefore, UTIs, and particularly complicated urinary tract infections cUTIs, are a target for repurposing of old and neglected drugs, new drug development and non-antibiotic therapeutic and preventive approaches.

Post-Emergency Optimization of Antibiotic Therapy for Urinary Tract Infection (UTI)

Prospective, multicenter, non-interventional study conducted over 6 months, including patients presenting to the emergency department with suspected urinary tract infection managed as outpatients and discharged with or without empiric antibiotic therapy. Discharge antibiotic prescriptions are reviewed, with subsequent reassessment and optimization of treatment based on urine culture and susceptibility results

Early vs Late Urinary Catheter Removal After Renal Transplantation

The purpose of this study is to compare frequency of UTI, urine leak and need for reoperation in patients after renal transplant with early or delayed Foley catheter removal. The hypothesis of the ELUCATR trial is that there is no need to keep Foley catheter longer than 24 hours after kidney transplant due to lack of significant effect on urological complications (urine leak, ureter strictures). Early removal can also reduce urinary tract infections. Main advantage of urinary catheter placement is continual diuresis monitoring and lower bladder pressure. Some hypothesize that increased pressure can disrupt ureteroneocystostomy with resultant urinary fistula. Clinical practice is to remove the catheter between 1-10 post-transplant day. Only few studies described removal of Foley catheter in the first 48 hours. There is no level 1 evidence for timing of urinary catheter removal after kidney transplantation. Urinary tract infection is a common complication after KTx occurring in about 7-80% patients. Studies suggest direct negative effect of UTI on long-term renal allograft function. There are several independent risk factors for developing UTI: female sex, diabetes and obesity. Duration of catheterization is a modifiable risk factor. Urine leak and ureter stenosis are relatively frequent surgical complications of kidney transplantation. Urine leaks occur in 2-9% of all kidney transplants. Most of them happen within 3 months after surgery. Urinary fistula contributes to mortality and graft loss. Majority of them need intervention with nephrostomy, pigtail ureteral stent or surgery. Anastomotic or ureter stenosis occurs in 3.1% of all kidney transplants and is usually resolved with open ureteroneocystostomy. Diagnosed and treated early, it does not affect patient and graft survival. There are no solid data documenting influence of the urinary bladder catheterization on fistulas, urinomas, ureter strictures and need for reoperation in this set of patients. European Best Renal Practice Guidelines recommend removal of the catheter as early as possible, however a randomized trial on timing and adverse event rates (urinary tract infection, urinary leakage) is needed.

Laser Therapy for Treatment of Urogenital Symptoms in Women

This is a prospective observational study of women undergoing vaginal treatment with the fractional carbon dioxide (fCO2) laser for various urogenital symptoms.

Effect of Hygiene and Menstrual Hygiene Interventions on Learning and Psychosocial Wellbeing in Madagascar

A previous study in schools in rural Madagascar found that a bundle of hygiene-focused interventions substantially improved girls' learning outcomes. This study disentangles the effects of physical infrastructure (latrines, handwashing basins) from other intervention components (peer sensitization and free sanitary pad distribution) in a cluster-randomized trial across 140 secondary schools in the Amoron'i Mania region. The trial originally measured learning and psychosocial wellbeing outcomes and was prospectively registered with the AEA RCT Registry (AEARCTR-0014423). The study team is now also collecting secondary health biomarker outcomes (e.g., salivary cortisol and blood-based C-reactive protein) and is registering those health biomarker endpoints with ClinicalTrials.gov.

Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting

Urinary tract infection (UTI) is when bacteria enter the urinary system and cause an infection. UTIs cause symptoms including burning when peeing, a feeling of an increased urge to pee, and cloudy or strong-smelling urine. Sometimes, severe UTIs can also cause fever, abdominal pain, and/or lower back pain. In the emergency department (ED), healthcare providers rely on symptoms, along with a urine analysis and a urine culture to diagnose a UTI. A urine analysis involves taking a sample of urine and analyzing different factors like color, acidity, presence of blood cells, presence of bacteria. An abnormal urine analysis increases the likelihood that patients might have a UTI, but it does not confirm it. A positive urine analysis will lead to provider's sending a sample of urine for a urine culture. A urine culture is used to grow whatever bacteria is in the collected urine. If growth is seen on the culture, then this confirms a patient has a UTI. This also specifies which bacteria grew on the culture. The lab can also take it a step further and do an antibiotic test to check which antibiotic the bacteria is sensitive to. When a urine analysis comes back abnormal in an ER setting, patients are prescribed an antibiotic before the culture and antibiotic sensitivity tests come back. If a patients condition is not critical, they will be discharged home before the culture results come back. If the culture comes back positive, the pharmacists will evaluate the culture and antibiotic sensitivity tests, then call patients to inform them whether they are taking a suitable antibiotic. This study aims to decrease the unnecessary use of antibiotics because this contributes to antibiotic resistance which is considered a global public health issue. Antibiotic resistance occurs when bacteria develop the ability to withstand certain antibiotics that used to be effective against them, which makes it difficult to treat the infection. One of the factors that increase the risk of antibiotic resistance is the overuse of antibiotics. In this study, investigators will be incorporating a prediction model and a negative callback system to decrease unnecessary antibiotic use.

Antibiotic Irrigation and Suction Ureteral Access Sheath in RIRS

Retrograde intrarenal surgery (RIRS) is a widely used treatment for kidney stones; however, postoperative infectious complications remain a significant concern. This prospective randomized factorial trial aims to evaluate whether gentamicin-containing irrigation fluid and the use of a suction ureteral access sheath can reduce postoperative fever, systemic inflammatory response syndrome (SIRS), and sepsis after RIRS. The study will also investigate the independent and combined effects of these two interventions on infectious outcomes.

WMT for Recurrent Urinary Tract Infections

his is a single-center, prospective, single-arm, interventional clinical study to evaluate the clinical efficacy, safety, and potential mechanisms of washed microbiota transplantation (WMT) in patients with recurrent urinary tract infections (rUTI). Recurrent UTI is defined as ≥2 episodes within 6 months or ≥3 episodes within 1 year. Traditional management relies heavily on antibiotics, which often lead to gut dysbiosis and increased infection risk. WMT may reconstruct intestinal microbiota, restore colonization resistance, and modulate immunity through the gut-bladder axis. Approximately 30 eligible patients will receive WMT via mid-gut or colonic transendoscopic enteral tubing (TET) for 2-3 times according to the Nanjing Consensus on Washed Microbiota Transplantation. Participants will be followed for 12 months.

Double Voiding and Post-transplant UTI

Urinary tract infections (UTI) are common in kidney transplant recipients and are an important cause of illness and hospital admissions. Past studies have shown that about 1 out of 5 of newly transplanted patients develop UTI within their first 3 months of transplantation. Such UTIs increase the risk for blood stream infection and acute rejection of the kidney, Improvements in urinary voiding techniques may reduce the frequency of UTI. The purpose of this study is to evaluate the benefits of "double voiding" in kidney transplant recipients.

Antibiotic Prophylaxis in Percutaneous Nephrostomy Placements and Replacements for Malignant Urinary Tract Obstruction

This study aims to find out whether taking antibiotics to prevent a urinary tract infection after a medical procedure called percutaneous nephrostomy (placement of a catheter directly into the kidney to keep it working after the urinary tract has been blocked by a malignant tumour) actually prevents a urinary tract infection, compared to not taking antibiotic prophylaxis.