Urinary Tract Infections

43

Review clinical trials related to Urinary Tract Infections. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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.

Participants needed: 180
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Hitit UniversityUpdated: Jun 24, 2026Locations: 2
Eligibility criteria

Patients scheduled for retrograde intrarenal surgery (RIRS) due to kidney stones [+3]

Patients with active urinary tract infection before surgery [+4]

Status: Recruiting

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

Participants needed: 330
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Centre Hospitalier Intercommunal CreteilUpdated: Jun 12, 2026Locations: 3
Eligibility criteria

Age 18 years or over [+1]

Refusal to participate in the study [+5]

Status: Not yet recruiting

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.

Participants needed: 8
Trial details
Phase: Phase 1Age: 18-50Biological sex: FemaleType: InterventionalSponsor: GlaxoSmithKlineUpdated: Jun 12, 2026
Eligibility criteria

Participants must be healthy lactating women, 18 to 50 years of age, inclusive,... [+8]

Participant is unwilling or unable to comply with the study restrictions or life... [+21]

Status: Recruiting

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.

Participants needed: 438
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Weill Medical College of Cornell UniversityUpdated: May 22, 2026Locations: 1
Eligibility criteria

All adult kidney transplant recipients who undergo routine follow-up at the New...

Kidney transplant recipients who are discharged after a transplant with an indwe...

Status: Not yet recruiting

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.

Participants needed: 20
Trial details
Phase: Phase 1Age: 2-11Biological sex: AllType: InterventionalSponsor: GlaxoSmithKlineUpdated: Apr 23, 2026
Eligibility criteria

Participants having ≥2 to <12 years of age at the time of signing the informed c... [+7]

Participants having a BMI-for-age that is less than the 5th percentile or greate... [+29]

Status: Not yet recruiting

Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.

The CATHETERS trial is a multicenter, randomized, open-label superiority study comparing two methods of managing urinary retention before surgery for benign prostatic hyperplasia (BPH): clean intermittent self-catheterization (ICSC) versus indwelling catheter (IDC). The primary objective is to determine whether ICSC reduces the occurrence of infectious complications (urinary bacterial colonization requiring antibiotic therapy, urinary tract infection, or urosepsis) compared to IDC in men awaiting BPH surgery. A total of 106 patients will be enrolled across multiple centers in France, with follow-up extending to three months after surgery.

Participants needed: 106
Trial details
Age: 50+Biological sex: MaleType: InterventionalSponsor: University Hospital, BordeauxUpdated: Apr 29, 2026Locations: 5
Eligibility criteria

Men over 50 years old; [+6]

Patient with a history of prostate surgery (including BPH surgery), prostatic ar... [+8]

Status: Recruiting

Effect of Comprehensive Spa Care on Kidney and Urological Conditions: A Clinical Study in Adult Patients

This is a single-arm, pretest-posttest study evaluating the effects of a 21-day comprehensive spa care (Komplexní lázeňská léčebně rehabilitační péče, KLP) on patients with nephrological and urological conditions treated at a spa facility in Mariánské Lázně, Czech Republic. The study enrolls 150 adult patients (75 men and 75 women), aged 40-70 years, who are prescribed KLP for indications VIII/1 (recurrent and chronic non-tuberculous inflammation of the kidneys and urinary tract), VIII/2 (nephrolithiasis without urinary tract obstruction, nephrocalcinosis), VIII/3 (conditions after kidney and urinary tract surgery), and VIII/4 (chronic prostatitis or prostatovesiculitis resistant to pharmacological treatment). The spa treatment consists of the use of natural healing resources of Mariánské Lázně, including a mineral spring drinking cure, balneotherapy (mineral water baths), peloid therapy, carbon dioxide therapy, climatotherapy, exercise therapy, and dietotherapy. The standard treatment duration is 21 days, during which each patient receives a total of 63 therapeutic procedures and drinks mineral spring water three times daily. Patients undergo assessments at the beginning (days 1-3) and at the end (days 19-21) of their treatment. Assessments include physical examination, abdominal and urinary tract ultrasound, blood and urine sampling with laboratory analysis, body composition measurement using bioelectrical impedance analysis (InBody), and psychometric questionnaire surveys. The primary aim of the study is to objectively assess the therapeutic effect of comprehensive spa care on nephrological and urological diseases by comparing pre-treatment and post-treatment clinical, laboratory, and patient-reported outcomes. The study was approved by the Ethics Committee of the University Hospital and Faculty of Medicine in Pilsen (decision of November 2, 2023, ref. no. 437/23).

Participants needed: 150
Trial details
Age: 40-70Biological sex: AllType: InterventionalSponsor: Institute of Spa and Balneology, public research institutionUpdated: Apr 24, 2026Locations: 1
Eligibility criteria

Male or female aged 40 to 70 years [+4]

Contraindications according to Czech Decree No. 2/2015 Coll. on spa treatment cr... [+8]

Status: Recruiting

A Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age

The purpose of this study is to assess safety, reactogenicity, and immune response of the candidate UTI vaccine compared to placebo in adults between and including 18-64 years of age (YOA), and to perform a preliminary evaluation of clinical efficacy in females between and including 18-64 YOA.

Participants needed: 448
Trial details
Phase: Phase 1, Phase 2Age: 18-64Biological sex: AllType: InterventionalSponsor: GlaxoSmithKlineUpdated: Apr 21, 2026Locations: 8
Eligibility criteria

Participants, who, in the opinion of the investigator, can and will comply with... [+10]

History of any reaction or hypersensitivity likely to be exacerbated by any comp... [+29]

Status: Recruiting

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.

Participants needed: 47
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University Hospitals Cleveland Medical CenterUpdated: Apr 8, 2026Locations: 1
Eligibility criteria

Female sex [+4]

Male sex [+6]

Status: Not yet recruiting

Electroacupuncture for the Prevention of Recurrent Lower Urinary Tract Infection in Women

The goal of this clinical trial is to evaluate if electroacupuncture works to prevent recurrent lower urinary tract infections in female patients. It will also learn about the safety of electroacupuncture. The main questions it aims to answer are: 1. Does electroacupuncture reduce the attacks of acute recurrent urinary tract infections in women? 2. What medical problems do participants have when taking electroacupuncture? Researchers will compare electroacupuncture to sham electroacupuncture to assess if electroacupuncture works to prevent recurrent lower urinary tract infections. Participants will: 1. Take electroacupuncture or sham electroacupuncture for 30 minutes per session over a 6-month period. During the first month, treatment was administered 3 times weekly (once every other day); the second month, 2 times weekly (once every 2-3 days); and the 3-6 month, once monthly. 2. Visit the hospital at the end of the 1st, 2nd, 3rd, and 6th months for follow-up evaluations. 3. Keep a diary of their symptoms and the number of times they use an antibiotic.

Participants needed: 312
Trial details
Age: 18-75Biological sex: FemaleType: InterventionalSponsor: Yanjun Zhang, Baoyan LiuUpdated: Apr 2, 2026Locations: 2
Eligibility criteria

Female patients aged 18-75 years; [+3]

Currently receiving prophylactic antibiotics for lower urinary tract infection; [+11]

Status: Not yet recruiting

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).

Participants needed: 150
Trial details
Phase: Phase 4Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of MiamiUpdated: Mar 30, 2026Locations: 2
Eligibility criteria

Women ≥ 18 years of age. [+5]

Contraindications to both oral antibiotics including antibiotic allergies or sig... [+8]

Status: Recruiting

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.

Participants needed: 318
Trial details
Phase: Phase 2Age: 18-75Biological sex: FemaleType: InterventionalSponsor: Locus BiosciencesUpdated: Mar 20, 2026Locations: 17
Eligibility criteria

History of UTI in the past 12 months and prior or current uUTI caused by AMR E.... [+7]

Signs or symptoms of systemic illness such as fever greater than 38° Centigrade/... [+12]

Status: Recruiting

Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture

Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.

Participants needed: 136
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospitals Cleveland Medical CenterUpdated: Mar 11, 2026Locations: 1
Eligibility criteria

Adult men and women 18 years and older [+2]

Urinary diversion of any type [+7]

Status: Recruiting

Intravenous Versus Oral Treatment of the Main Acute Infections

Patients admitted to the hospital with acute infections are often treated with intravenous (IV) antibiotics. Around 70% of these infections fall into three categories: respiratory tract infections, urinary tract infections, and cellulitis. A Danish study found that 76% of patients admitted with suspected community-acquired pneumonia and treated with antibiotics received them intravenously. Based on an extrapolated estimate from an unpublished local survey, approximately 50,000 patients in Denmark are admitted each year for infections and treated with IV antibiotics. The average hospital stay for these patients is 5.9 days, resulting in a total of 295,000 hospital days annually, accounting for about 7% of total hospital admissions in Denmark. This represents an annual cost of 2.3 billion DKK. While some patients need hospitalization due to their overall health or other serious conditions, others remain hospitalized primarily to receive IV antibiotics. Expanding the use of oral antibiotics in emergency departments should be pursued only if it can demonstrate comparable efficacy and safety to IV administration. Therefore this study will investigate the efficiency of primarily oral antibiotics in acutely admitted patients with proven or suspected infections. Additionally, the investigators will evaluate the safety of oral regimen for these patients.

Participants needed: 4,000
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of Southern DenmarkUpdated: Mar 5, 2026Locations: 7
Eligibility criteria

Suspected respiratory tract infection, urinary tract infection, or cellulitis by... [+1]

if received more than two doses of intravenous antibiotics; [+8]

Status: Recruiting

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.

Participants needed: 75
Trial details
Age: 14-110Biological sex: FemaleType: ObservationalSponsor: Antonios LikourezosUpdated: Mar 4, 2026Locations: 1
Eligibility criteria

female emergency medicine patients [+3]

pregnancy [+9]

Status: Not yet recruiting

Vitamin C and Hiprex in rUTI

A single centre proof of concept study to assess whether Vitamin C improves the efficacy of Methenamine Hippurate (Hiprex®) in the prophylaxis of recurrent urinary tract infections (rUTIs) in women

Participants needed: 20
Trial details
Phase: Early Phase 1Age: 18+Biological sex: FemaleType: InterventionalSponsor: University Hospitals of North Midlands NHS TrustUpdated: Feb 11, 2026Locations: 1
Eligibility criteria

Female [+9]

Males [+11]

Status: Not yet recruiting

Metaphylaxis of Infected Kidney Stones After Percutaneous Nephrolithotripsy

Kidney stone recurrence, particularly infection-related stones, remains a significant clinical problem after percutaneous nephrolithotripsy (PCNL). Bacterial colonization and persistent infection are recognized contributors to stone recurrence. This study evaluates the effectiveness of intrarenal dioxidine instillation as a metaphylactic measure to reduce recurrence of infection-related kidney stones following PCNL. Patients undergoing PCNL will receive standard treatment, with or without adjunctive intrarenal dioxidine administration. The study aims to assess whether this approach reduces stone recurrence and infection-related complications.

Participants needed: 95
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: West Kazakhstan Marat Ospanov Medical UniversityUpdated: Feb 11, 2026Locations: 1
Eligibility criteria

Not listed

Status: Not yet recruiting

Evaluation of Safety and Efficacy of Phage Therapy for Drug-resistant Bacterial Infections: An Exploratory, Prospective Single-arm Study

This study is an investigator-initiated, single-center, exploratory clinical trial designed to evaluate the safety and efficacy of phage therapy in patients with urinary tract infections caused by drug-resistant bacteria. Eligible patients aged 18 to 65 years will receive the phage cocktail intervention according to a predefined dosage regimen, with a treatment course of 2 to 3 days and a follow-up period of 2 to 4 weeks after treatment. The primary outcome measures include the incidence of adverse events during treatment, the pathogen clearance rate, and the improvement of clinical symptoms (e.g., fever, local inflammation). The purpose of this study is to provide a scientific basis for the subsequent clinical application of this phage cocktail, and to explore a novel therapeutic option for patients with drug-resistant bacterial infections who have shown poor responses to conventional antibiotic therapy. All participants will undergo standardized medical monitoring throughout the trial, and their rights and safety will be fully protected by the Institutional Review Board (IRB) during the entire process.

Participants needed: 6
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUpdated: Feb 2, 2026
Eligibility criteria

1. Aged 18-65 years old. 2. Patients with urinary tract infections caused by dru... [+5]

1. Bacterial infection controllable with conventional antibiotic therapy. 2. Pre...

Status: Recruiting

Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial

Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.

Participants needed: 2,674
Trial details
Age: Up to 18Biological sex: AllType: InterventionalSponsor: University of UtahUpdated: Dec 10, 2025Locations: 14
Eligibility criteria

Age <18 years at the time of randomization [+2]

Presence of a comorbid disease that is both chronic and complex [+16]

Status: Recruiting

NextGen - Clinical Implication of Next Generation Sequencing

Recently more advanced techniques, including Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) are available to detect bacteria in urine based on bacterial genomes. Comparing to traditional culture, these techniques have more sensitivity and could potentially be of a great help in patients with Colony Count of less than 10,000 and more than zero.

Participants needed: 100
Trial details
Phase: Phase 4Age: 18-80Biological sex: FemaleType: InterventionalSponsor: Wake Forest University Health SciencesUpdated: Dec 8, 2025Locations: 1
Eligibility criteria

Female at least 18 years of age [+3]

Catheter in use (Foley or suprapubic or intermittent) [+4]

Status: Not yet recruiting

Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization - A Randomised-Controlled Trial

Community-acquired infections such as community-acquired pneumonia (CAP) and urinary tract infection (UTI) remain leading causes of hospitalization and death due to infections in older persons in Europe. Hospitalization often results in further disabilities and frailty for older and frail individuals, from which some may never recover. Physical activity is well-established as a cornerstone in the primary prevention and treatment of several noncommunicable diseases. However, there is currently no established rehabilitation model following a pneumonia or other infection, nor is there any evidence to support the impact of rehabilitation on the mental and physical health of older and frail individuals following a pneumonia hospitalization or other infection. The aim of the feasibility study is to evaluate a patient-centered and individualized exercise intervention that is kick-started during hospitalization and continued for 3 months after discharge with video-supervised home-based exercise training to patients hospitalized with CAP or UTI compared to standard care with regard to safety, clinical outcomes, patients' perception, functional ability, organizational aspects, and economic aspects.

Participants needed: 460
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Nordsjaellands HospitalUpdated: Dec 2, 2025Locations: 3
Eligibility criteria

Patients aged ≥65 years or 18-64 years if the presence of at least one chronic d... [+6]

Hospitalization within the past 14 days. [+7]

Status: Not yet recruiting

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.

Participants needed: 480,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Jacob BodilsenUpdated: Oct 1, 2025Locations: 2Duration: 30 Days
Eligibility criteria

All patients admitted to emergency rooms (≥18 years) from 2019 and forward.

Patients directly admitted to an inpatient unit without first visiting an emerge... [+1]

Status: Recruiting

Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers

This Phase I study is a randomized, double-blind, placebo-controlled, dose-escalation trial conducted at a single center. It consists of two parts: Part 1 (SAD): Evaluates the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous doses of JKN2501 in healthy adults. Biological samples (blood, urine, feces) will be collected for PK analysis. Part 2 (MAD): Evaluates the safety, tolerability, and PK of multiple ascending intravenous doses of JKN2501 in healthy adults. Dose levels may be adjusted based on emerging safety, tolerability, and PK data from preceding cohorts.

Participants needed: 66
Trial details
Phase: Phase 1Age: 18-45Biological sex: AllType: InterventionalSponsor: Joincare Pharmaceutical Group Industry Co., LtdUpdated: Oct 3, 2025Locations: 1
Eligibility criteria

Voluntary informed consent; able to comply with study requirements and communica... [+4]

Pregnant/lactating women; positive pregnancy test; unprotected sex within 2 week... [+18]

Status: Recruiting

Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis

This open-label, parallel-group randomized controlled trial compares two prophylaxis strategies for recurrent urinary tract infection (rUTI) in postmenopausal women: (1) nightly oral nitrofurantoin 100 mg for 6 months versus (2) a vaginal tablet containing Lactobacillus with ultra-low-dose estriol (Gynoflor: nightly for 14 days, then twice weekly to month 6). Participants (≥40 years) are randomized 1:1 in computer-generated blocks and followed for 6 months. The primary endpoint is the proportion with rUTI recurrence within 6 months. Secondary endpoints include time to first recurrence, antibiotic resistance in breakthrough infections, change in lower urinary tract symptoms (Thai RUTISS), and urinary microbiome measures (Lactobacillus dominance and community diversity by qPCR and 16S rRNA). Key assessments occur at baseline and month 6 (urinalysis, culture, urinary microbiome sampling, and kidney function). Adherence and adverse events are captured via twice-weekly phone/Line contacts. Approximately 100 participants (50 per arm) will be enrolled as a feasibility-sized pilot.

Participants needed: 100
Trial details
Phase: Phase 4Age: 40+Biological sex: FemaleType: InterventionalSponsor: Mahidol UniversityUpdated: Sep 25, 2025Locations: 1
Eligibility criteria

Female, postmenopausal, age ≥40 years [+5]

Current symptomatic UTI at enrollment (may be treated and reconsidered after res... [+7]

Status: Recruiting

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is a major public health problem. It leads more frequent prescription of penems with the risk of emergence and spread of strains producing carbapenemases, which may be resistant to all known antibiotics. A policy of savings of penems is desirable. Among the alternatives to penems, amikacin is in the foreground. It remains active on the majority of E-ESBL strains. Some risk factors for E-ESBL emergence are known: recent antibiotic therapy (particularly quinolones and cephalosporins third generation), previous hospitalization or residence in a high endemic country. In pediatrics, E-ESBLs are primarily responsible for urinary tract infection. In France, E-ESBLs represent about 10% of the strains responsible for urinary tract infections. The Pathology Group Pediatric Infectious (GPIP) of the French Society of Pediatrics (SFP) and the Society of Infectious Pathology French Language (SPILF) have proposed different therapeutic options to treat febrile UTIs in children: amikacin intravenous; intravenous (IV) ceftriaxone or intramuscular (IM); or cefixime per-os (PO). The objective of this study is to compare the emergence of E-ESBLs in stools of children after febrile UTIs treatment with amikacin IV versus ceftriaxone or cefixime.

Participants needed: 200
Trial details
Age: 3-3Biological sex: AllType: ObservationalSponsor: Centre Hospitalier Intercommunal CreteilUpdated: Aug 27, 2025Locations: 20
Eligibility criteria

Infant and child (age ≥ 3 months and <3 years) [+3]

Child treated with more than one antibiotic (eg treatment with dual therapy ceft... [+3]