Pyelonephritis (Kidney Infection)

This research aims to improve the diagnosis of urinary tract infections (UTI) in older adults aged 65 years and above. It focuses on finding the best cut-off values for individual urine biomarkers such as NGAL, IL-6, AZU, TIMP2, and CXCL9, along with assessing the sensitivity, specificity, and predictive values of these markers. The study also seeks to validate urine leukocyte count cut-offs and evaluate the combination of biomarkers for better diagnosis. Additionally, it will explore how biomarker levels relate to symptom duration, complications, recurrence within two months, and hospital stay length. The performance of the astrego PA100 device in detecting bacteriuria will also be validated. Participants will provide a midstream urine sample once at the start of the study, which will be collected in a sterile container for biomarker testing. They will answer questions about their symptoms and general health at the beginning and again after eight weeks. Vital signs, including temperature and blood pressure, will be measured once at the start. This observational study does not involve any treatment but focuses on diagnostic assessments. During the study, participants will be monitored for symptoms and potential complications. Researchers will track symptom duration, hospital stay lengths, and recurrence of UTI over an eight-week period. Diagnostic accuracy of individual biomarkers and their combinations will be evaluated at baseline. The study will also assess the diagnostic performance of the PA100 device for bacteriuria detection. Overall participation involves two assessments and one urine sample collection, spanning about eight weeks from inclusion to follow-up.

This research aims to evaluate antibiotic treatments for acute pyelonephritis (AP) in children aged 1 month to 3 years. It compares a shorter intravenous (IV) antibiotic course of 3 days alone to a longer treatment consisting of 3 days IV followed by 7 days of oral antibiotics. The goal is to see if the shorter IV treatment is as effective in curing AP and preventing recurrence and renal scarring, while reducing the risk of antibiotic resistance and preserving gut microbiota diversity. Participants are randomly assigned to one of two groups. The experimental group receives only 3 days of IV antibiotics with ceftriaxone and/or amikacin, after which treatment is stopped. The control group receives the usual care of 3 days IV antibiotics followed by 7 days of oral antibiotics, either cotrimoxazole or cefixime. The study includes collection of fecal or rectal swabs and blood tests to assess microbiota and resistance. Treatment effectiveness and safety are compared between groups. During the study, children are monitored for fever, symptoms, and urine cultures to confirm infection clearance. Researchers measure recurrence of febrile urinary tract infections within 28 days after treatment ends and follow clinical cure at 10 or 17 days depending on the group. Additional assessments include monitoring recurrence at 90 days, antimicrobial resistance in gut bacteria, and intestinal microbiota diversity over about a month. Participation lasts through treatment and follow-up visits up to several weeks.

Researchers are investigating why some men with Benign Prostatic Hyperplasia (BPH), a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.

Researchers are evaluating whether using an automated Carbon Dioxide (CO2) injection system during infrainguinal peripheral vascular interventions (PVI) can reduce major adverse kidney events within 90 days in patients at moderately increased risk for contrast-associated acute kidney injury (CA-AKI). This Phase 3 randomized controlled trial compares a CO2-based contrast medium sparing strategy to the standard use of iodinated contrast media in patients with peripheral vascular and kidney diseases. Participants are randomly assigned to one of two groups. The intervention group receives PVI using an automated CO2 injection system as the primary contrast agent, with iodinated contrast media available as a backup if image quality is insufficient or if the patient cannot tolerate CO2 angiography. The control group undergoes routine PVI using iodinated contrast media according to local standards, avoiding high-osmolar contrast agents. All patients are followed for up to 12 months after their procedure. During the study, participants undergo the planned PVI procedure with either contrast method. Researchers carefully record the amount and reasons for any iodinated contrast media used in the CO2 group. Patients are monitored for kidney-related outcomes, focusing on major adverse kidney events up to 90 days after the intervention. The trial includes ongoing follow-up assessments to evaluate safety and effectiveness over one year.

This research aims to evaluate a new approach for preventing recurrent urinary tract infections (UTIs) in children and adolescents aged 2 to 17 years. It compares the use of a probiotic called Saccharomyces Boulardii combined with an antibiotic, ciprofloxacin, given when a UTI occurs, against standard care treatments. The study focuses on patients with a history of multiple UTIs and certain urinary tract conditions, aiming to reduce the number of UTI episodes over six months. Participants will receive the probiotic Saccharomyces Boulardii once daily for six months regardless of symptoms. At enrollment, all participants will be provided with ciprofloxacin. Those who have UTI symptoms or a positive urine culture at the start will take ciprofloxacin every 12 hours for 14 days. Those without symptoms will take the antibiotic only if a UTI occurs later. All participants will continue to receive standard clinical care, including management of bowel and bladder function and other non-antibiotic treatments as determined by their healthcare providers. Throughout the study, participants will be monitored for UTI episodes, with the primary outcome being the reduction in UTI episodes over six months. Researchers will track adherence to the probiotic and antibiotic regimens and standard care practices. Safety and tolerability will be observed, and participants’ health will be assessed through clinical visits and urine cultures as needed. The study duration and follow-up ensure careful observation of the treatments’ effects and participants’ well-being.

Researchers are conducting a prospective national registry in Denmark to observe and collect data on percutaneous transluminal renal angioplasty (PTRA) in patients who have high-risk renovascular hypertension. This registry includes patients selected based on common national criteria and follows a standardized protocol across three Danish centers offering PTRA. The study aims to evaluate changes in blood pressure and other health outcomes after the procedure. The intervention being studied is percutaneous transluminal renal angioplasty, including angioplasty with stenting, especially in patients with fibromuscular dysplasia. Additional treatments such as antiplatelet therapy, cholesterol-lowering drugs, antihypertensive medications, and lifestyle measures like smoking cessation, diet, and physical activity are used according to the physician's discretion. The study monitors patients over time following their PTRA treatment. Participants undergo regular assessments including 24-hour ambulatory blood pressure monitoring and kidney function tests. The primary outcome measured is the change in systolic and diastolic blood pressures 24 months after PTRA in patients with elevated baseline blood pressure. Secondary outcomes include blood pressure changes at multiple time points, adjustments in antihypertensive treatment, kidney function changes, clinical and safety endpoints. Follow-up evaluations occur up to 60 months post-treatment to monitor long-term effects and safety.

Researchers are evaluating the long-term effects of enavogliflozin, a new sodium-glucose cotransporter-2 (SGLT2) inhibitor, in adults aged 19 and older with type 2 diabetes who have or are at risk for cardiovascular disease. This study aims to determine if enavogliflozin is not less effective than other SGLT2 inhibitors like dapagliflozin or empagliflozin in reducing major heart and kidney problems. The trial is a multicenter, randomized, open-label, active-controlled, non-inferiority study focusing on cardiorenal outcomes in the Korean population. Participants will be randomly assigned to receive enavogliflozin or either dapagliflozin or empagliflozin, with the dosing and administration guided by the investigator based on approved use and the participant's medical condition. The study includes an initial treatment period with follow-up assessments up to 48 months to monitor outcomes. The primary measurement is the time to the first major heart or kidney event, while secondary outcomes include rates of heart attacks, hospitalizations, deaths, kidney events, and progression of kidney damage. During the study, participants will have regular evaluations at 6, 12, 24, 36, and 48 months to assess cardiovascular and kidney health. Researchers will monitor hospitalizations, deaths, and kidney function changes using clinical records and laboratory tests. This long-term follow-up aims to clarify the role of enavogliflozin in preventing vascular complications in patients with type 2 diabetes and cardiovascular risk factors, with safety and outcomes carefully tracked throughout the study period.

This research focuses on adult patients with sepsis caused by abdominal infections, aiming to understand the progression of entero-renal syndrome. The study compares patients who survive with those who do not by examining gastrointestinal function, blood flow in the superior mesenteric artery, and the renal artery resistance index. Researchers seek to provide reliable information to improve clinical decision-making and rescue success rates. Participants undergo ultrasound examinations to measure the gastric antrum cross-sectional area, colon diameter, colon peristalsis frequency, and renal artery resistance index. These measurements are taken at multiple time points: upon ICU admission, and then 6, 24, 48, 72, and 120 hours later. Additional monitoring includes central venous pressure, oxygen saturation, inflammatory markers, blood lactic acid, blood creatinine, fluid intake, and bladder pressure. During the study, participants are monitored closely in the ICU with data collected to assess survival outcomes. The main outcome measures focus on the resistance indices of the superior mesenteric artery and renal artery at admission and at 24 and 72 hours post-admission. This observational study extends up to 120 hours with ongoing assessments to better understand the syndrome’s progression and support clinical care for sepsis patients.

Researchers are evaluating LBP-EC01, a recombinant bacteriophage cocktail, in a Phase 2 study for women with acute uncomplicated urinary tract infections (UTI) caused by drug-resistant E. coli. The study aims to find the best dosing regimen and compare the treatment's safety, tolerability, pharmacokinetics, and effectiveness against placebo when combined with an antibiotic, trimethoprim/sulfamethoxazole (TMP/SMX). Eligible participants must have an active acute UTI at the start and a history of prior UTI caused by antimicrobial-resistant E. coli. The study has two parts. Part 1 is an open-label dose regimen selection with 30 patients divided into three groups receiving different doses of LBP-EC01 via intraurethral and intravenous administration alongside oral TMP/SMX over three days. Part 2 is a double-blind, randomized comparison of the selected LBP-EC01 dose regimen versus placebo, both with oral TMP/SMX, in 288 patients. Treatment in Part 2 lasts three days, with doses given twice daily for TMP/SMX and specified LBP-EC01 doses on days 1 to 3. Participants will provide urine, blood, and stool samples for microbiological and pharmacokinetic analyses. Researchers will monitor clinical symptoms, microbiologic responses, adverse events, and immunogenicity over several follow-up visits up to six months. The main outcomes include drug levels in urine and blood, symptom resolution, and microbiological cure by day 10. Safety and tolerability are also closely observed throughout the study.

Researchers are evaluating the safety and activity of sparsentan for treating adult patients with biopsy-confirmed immunoglobulin A nephropathy (IgAN), including newly diagnosed patients who have not received prior ACEI or ARB therapy (Cohort A) and patients with recurrent IgAN after kidney transplantation (Cohort B). This open-label, multi-center trial aims to explore sparsentan's potential to protect kidney function over an extended period. In Cohort A, patients will start sparsentan at 200 mg daily, increasing to a target dose of 400 mg daily after two weeks if tolerated, with dose adjustments allowed to maintain the highest tolerable dose. Treatment will continue for 110 weeks, followed by a 4-week off-treatment follow-up. Cohort B patients will be randomly assigned to receive sparsentan plus standard care for 48 weeks or standard care alone for 24 weeks before adding sparsentan for the remaining 24 weeks, then followed by a 4-week follow-up. Additional antihypertensive treatments are allowed except for ACEIs, ARBs, aldosterone blockers, or aliskiren. Participants will undergo assessments including urine protein excretion, estimated and measured glomerular filtration rate (GFR), kidney biopsy analysis using the Oxford Classification, MRI for kidney and heart function, bioimpedance for body water, and quality of life evaluations. Safety will be monitored through adverse events, lab tests, and vital signs. The primary outcome is urine protein/creatinine ratio at Week 36, with secondary outcomes assessing kidney function, proteinuria changes, and safety over up to 114 weeks.