Ongoing Clinical Trials for Urinary Tract Infection
There are currently 15 clinical trials investigating new treatments for urinary tract infection across multiple countries in Europe. These trials are testing various antibiotics and therapeutic approaches, including combination medications, vaccines, and microbiota-based therapies, to improve treatment outcomes for patients with uncomplicated and complicated infections.
Clinical trial locations
- Belgium
- Study of meropenem-vaborbactam safety and effectiveness in children aged 3 months to 12 years with complicated urinary tract infection or acute pyelonephritis
- Study on the Safety and Effectiveness of a UTI Vaccine (GSKVX000000046019) for Adults Aged 18-64 and Women Aged 18-64 with Urinary Tract Infections
- Bulgaria
- Study of meropenem-vaborbactam safety and effectiveness in children aged 3 months to 12 years with complicated urinary tract infection or acute pyelonephritis
- Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
- Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Complicated Urinary Tract Infections or Acute Pyelonephritis
- Croatia
- Czechia
- Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
- Study on the Safety and Absorption of Meropenem and Vaborbactam in Children with Complicated Urinary Tract Infections
- Study on Cefepime and Enmetazobactam for Children with Complicated Urinary Tract Infections, Including Acute Pyelonephritis
- Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Complicated Urinary Tract Infections or Acute Pyelonephritis
- Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections
- Denmark
- Estonia
- France
- Study on E. coli Polysaccharide for Reducing Antibiotic Use in Patients with Neurogenic Bladder and Recurrent Urinary Tract Infections
- Study on the Safety and Absorption of Meropenem and Vaborbactam in Children with Complicated Urinary Tract Infections
- A study of fosfomycin trometamol treatment for male urinary tract infections in primary care settings
- Study on Cefepime and Enmetazobactam for Children with Complicated Urinary Tract Infections, Including Acute Pyelonephritis
- Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections
- Germany
- Greece
- Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
- Study of meropenem-vaborbactam safety and effectiveness in children aged 3 months to 12 years with complicated urinary tract infection or acute pyelonephritis
- Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
- Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections
- Hungary
- Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
- Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
- Study on Cefepime and Enmetazobactam for Children with Complicated Urinary Tract Infections, Including Acute Pyelonephritis
- Italy
- Study on the Safety and Absorption of Meropenem and Vaborbactam in Children with Complicated Urinary Tract Infections
- Study of Intravenous Fosfomycin, Tazobactam Sodium, and Ertapenem Sodium for Hospitalized Patients with Complicated Urinary Tract Infections
- Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
- Latvia
- Lithuania
- Poland
- Study of meropenem-vaborbactam safety and effectiveness in children aged 3 months to 12 years with complicated urinary tract infection or acute pyelonephritis
- Study on the Safety and Absorption of Meropenem and Vaborbactam in Children with Complicated Urinary Tract Infections
- Study on Cefepime and Enmetazobactam for Children with Complicated Urinary Tract Infections, Including Acute Pyelonephritis
- Slovakia
- Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
- Study on Cefepime and Enmetazobactam for Children with Complicated Urinary Tract Infections, Including Acute Pyelonephritis
- Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Complicated Urinary Tract Infections or Acute Pyelonephritis
- Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections
- Spain
- Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
- Study of meropenem-vaborbactam safety and effectiveness in children aged 3 months to 12 years with complicated urinary tract infection or acute pyelonephritis
- Study on the Safety and Absorption of Meropenem and Vaborbactam in Children with Complicated Urinary Tract Infections
- Study on the Safety and Effectiveness of a UTI Vaccine (GSKVX000000046019) for Adults Aged 18-64 and Women Aged 18-64 with Urinary Tract Infections
- Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
- Study on Cefepime and Enmetazobactam for Children with Complicated Urinary Tract Infections, Including Acute Pyelonephritis
- Study on the Safety and Effectiveness of Fosfomycin Calcium for Treating Uncomplicated Urinary Tract Infections in Adult Women
- Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections
- Sweden
Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
This trial is testing a combination of aztreonam-avibactam and metronidazole in children aged 9 months to less than 18 years who have serious infections caused by gram-negative bacteria. These infections can include complicated conditions affecting the urinary tract, abdomen, lungs, or bloodstream.
Who can participate: Children between 9 months and 18 years old who require hospitalization and intravenous antibiotic treatment for suspected or confirmed gram-negative bacterial infections. Female participants who have started menstruating must have a negative pregnancy test.
Who cannot participate: Children with other serious unrelated infections, known allergies to the study medications, those currently in another clinical trial, pregnant or breastfeeding participants, or those with a history of substance abuse or conditions affecting their ability to follow study instructions.
Treatment approach: The trial aims to evaluate the safety and effectiveness of aztreonam-avibactam combined with metronidazole compared to the best available standard treatment. Aztreonam works by killing bacteria, while avibactam helps prevent bacteria from breaking down the antibiotic, making the combination more effective. Metronidazole is added to help treat certain abdominal infections.
Throughout the study, participants will be closely monitored with regular assessments of liver and kidney function, blood tests to measure medication levels, and evaluations of how well the infection responds to treatment.
Study of meropenem-vaborbactam safety and effectiveness in children aged 3 months to 12 years with complicated urinary tract infection or acute pyelonephritis
This study examines the safety and tolerability of Vabomere, which contains meropenem and vaborbactam, in children aged 3 months to 12 years with complicated urinary tract infections or acute pyelonephritis, a serious kidney infection.
Who can participate: Children aged 3 months to 12 years who require hospital admission for at least 3 days of intravenous antibiotic treatment. Participants must show signs of urinary infection through urine testing and display at least two symptoms appropriate for their age, such as fever, pain during urination, or frequent urination. The child’s parent or legal guardian must provide written consent.
Who cannot participate: Children with severe kidney problems affecting medication clearance, known allergies to similar antibiotics, those currently taking medications that could interact with Vabomere, or pregnant and breastfeeding adolescents.
Treatment approach: Vabomere combines meropenem, an antibiotic that kills bacteria, with vaborbactam, which prevents certain bacteria from breaking down meropenem. This makes the treatment more effective against infections caused by bacteria that are difficult to treat with other antibiotics. The medication is given through an intravenous infusion, with the total treatment lasting between 7 to 14 days.
The study will monitor blood and urine samples, vital signs, and any side effects throughout the treatment period and during follow-up visits.
Study of Pivmecillinam and Amoxicillin/Clavulanic Acid for Treating Urinary Tract Infections in Patients with Multidrug-Resistant Bacteria
This trial investigates alternative oral antibiotics for treating febrile urinary tract infections caused by ESBL-producing bacteria, which are resistant to many common antibiotics.
Who can participate: Adult men and women aged 18 or older with a positive urine or blood test for ESBL-producing bacteria who have already received 1-5 days of intravenous antibiotic treatment. Participants must have experienced fever and show signs of a urinary tract infection. The doctor must determine it is safe to switch from intravenous to oral antibiotics.
Who cannot participate: Patients with known allergies to the study medications, those who are pregnant or breastfeeding, individuals with severe liver or kidney disease, those with compromised immune systems, or anyone unable to take oral medications.
Treatment approach: The trial tests pivmecillinam and amoxicillin/clavulanic acid as oral alternatives after initial intravenous treatment. Pivmecillinam stops bacterial growth by interfering with cell wall formation, while amoxicillin/clavulanic acid combines an antibiotic with a substance that prevents bacteria from becoming resistant.
Participants will be monitored for clinical response and will have a follow-up urine culture 7 to 10 days after completing antibiotics to ensure the infection has cleared.
Study on E. coli Polysaccharide for Reducing Antibiotic Use in Patients with Neurogenic Bladder and Recurrent Urinary Tract Infections
This trial evaluates whether OM-89, a bacterial vaccine made from parts of E. coli bacteria, can reduce the need for antibiotics in treating recurrent urinary tract infections in patients with neurogenic bladder caused by spinal cord injury.
Who can participate: Patients aged 18 or older with a stabilized neurogenic bladder following a spinal cord injury for more than 2 years. They must use clean intermittent catheterization 5 to 6 times daily and have received at least 6 courses of antibiotic treatment for urinary tract infections in the past 12 months. A urodynamic examination must have been performed within the last 2 years.
Who cannot participate: Patients without spinal cord injury or stabilized neurogenic bladder, those not using clean intermittent catheterization, individuals outside the age range of 18 to 65, or those unwilling to participate for the study duration.
Treatment approach: OM-89 is an experimental medication being tested to see if it can prevent recurrent infections, potentially reducing antibiotic use. Participants will receive either OM-89 or a placebo over a 12-month period, with their quality of life and infection frequency monitored through regular follow-up visits.
Study on Shortened Antibiotic Treatment for Gram-negative Bacteremia in Hospitalized Adults Using Pivmecillinam Hydrochloride and Drug Combination
This study compares a shorter 5-day course of antibiotic treatment with the traditional 7-day or longer course for treating gram-negative bacteremia that originates from a urinary tract infection.
Who can participate: Adults over 18 years old with a positive blood culture for gram-negative bacteria and evidence of a urinary tract infection. Participants must have started appropriate antibiotic treatment within 12 hours of the first positive blood test and be clinically stable with normal temperature, blood pressure, heart rate, breathing rate, and oxygen levels.
Who cannot participate: Individuals under 18, those with weakened immune systems, or members of vulnerable populations requiring special protection.
Treatment approach: The trial tests whether a shorter duration of antibiotic treatment is as effective and safe as longer courses. Participants will be randomly assigned to receive either 5 days or 7 days or more of antibiotics, with their health monitored for up to 90 days to assess survival rates, side effects, and any need for additional antibiotics.
Study on the Safety and Absorption of Meropenem and Vaborbactam in Children with Complicated Urinary Tract Infections
This trial studies how Vaborem, a combination of meropenem and vaborbactam, is absorbed and tolerated in children aged 3 months to less than 18 years with complicated urinary tract infections, including acute pyelonephritis.
Who can participate: Children between 3 months and 18 years old who require hospitalization for complicated urinary tract infections or acute pyelonephritis and need at least 3 days of intravenous antibiotic treatment. A parent or legal representative must provide written informed consent, and the child should give their agreement if old enough.
Who cannot participate: Children outside the specified age range or those unable to receive multiple doses of the study medication through intravenous infusion.
Treatment approach: Vaborem combines meropenem, which kills bacteria, with vaborbactam, which helps prevent bacteria from breaking down meropenem. This combination is administered through intravenous infusion. The study will monitor how the medication is processed in the body, measure drug levels in the blood, and track any side effects or changes in laboratory test results.
Study on the Safety and Effectiveness of a UTI Vaccine (GSKVX000000046019) for Adults Aged 18-64 and Women Aged 18-64 with Urinary Tract Infections
This clinical trial tests a vaccine designed to prevent urinary tract infections caused by E. coli bacteria in adults aged 18 to 64.
Who can participate: Adult women aged 18 to 64 who can follow the study rules and provide written consent. For the second part of the study, female participants must have had at least one episode of a urinary tract infection caused by E. coli confirmed by a urine test in the past 12 months. Women of childbearing potential must use effective birth control and have a negative pregnancy test.
Who cannot participate: Patients currently experiencing a urinary tract infection, those who had an E. coli infection in the past 3 months, individuals with known allergies to vaccine components, pregnant or breastfeeding women, those with weakened immune systems, or anyone who received another vaccine within the last 4 weeks.
Treatment approach: Participants will receive two doses of the UTI vaccine or placebo as an intramuscular injection. The vaccine aims to help the body build protection against E. coli bacteria by stimulating the immune system. The study will monitor participants for any side effects, reactions to the vaccine, and its ability to prevent new infections over approximately 12 months.
A study of fosfomycin trometamol treatment for male urinary tract infections in primary care settings
This study evaluates the effectiveness of fosfomycin trometamol, given as a 14-day oral treatment, for men with urinary tract infections receiving care from their family doctor.
Who can participate: Men aged 18 or older under the care of a general practice physician with suspected male urinary tract infection. Participants must have at least one recent symptom such as burning during urination, urgent need to urinate, frequent urination, painful urination, blood in urine, or pelvic pain that appeared within the last 3 months.
Who cannot participate: Individuals below 18 or above 65 years, those with known allergy to fosfomycin trometamol, severe kidney problems, current fever above 38.5°C, permanent urinary catheter, diagnosed prostate cancer, recent urinary tract surgery, immune system disorders, severe liver disease, uncontrolled diabetes, or history of recurring urinary tract infections.
Treatment approach: Fosfomycin trometamol is an antibiotic that stops bacterial growth. The medication comes as granules dissolved in water and taken by mouth once daily for 14 days. The study will monitor symptom improvement through follow-up visits at various points during and after treatment, including urine tests to check if the infection has cleared.
Study of Intravenous Fosfomycin, Tazobactam Sodium, and Ertapenem Sodium for Hospitalized Patients with Complicated Urinary Tract Infections
This trial compares intravenous fosfomycin with the best available therapy for treating complicated urinary tract infections caused by third-generation cephalosporin-resistant bacteria in hospitalized patients.
Who can participate: Adult men and women with complicated urinary tract infections showing at least 100,000 bacteria per milliliter in urine testing. The bacteria must be resistant to common antibiotics but treatable with fosfomycin. Participants must be able to make decisions for themselves.
Who cannot participate: Patients with known allergies to study medications, those who are pregnant or breastfeeding, individuals with severe liver or kidney disease requiring dialysis, participants in another clinical trial within the last 30 days, those with a history of drug or alcohol abuse, or anyone unable to comply with study procedures.
Treatment approach: Fosfomycin is given intravenously to kill bacteria or stop their growth. The study will compare its effectiveness with standard treatments over a treatment period of up to 14 days. Clinical response will be monitored 5 to 7 days after treatment ends, with follow-up observations continuing for up to 90 days.
Study on Aztreonam, Avibactam, and Metronidazole for Treating Infections in Neonates and Infants Under 9 Months with Gram-Negative Bacterial Infections
This trial studies the combination of aztreonam, avibactam, and metronidazole in newborns and infants under 9 months old with serious infections caused by gram-negative bacteria.
Who can participate: Hospitalized infants from birth to less than 9 months old, including those born preterm, who are receiving intravenous antibiotics for suspected or confirmed bacterial infections. These infections can include complicated urinary tract infections, complicated intra-abdominal infections, hospital-acquired pneumonia, ventilator-associated pneumonia, bloodstream infections, or sepsis.
Who cannot participate: Patients with known allergies to study medications, those who participated in another clinical trial within the last 30 days, infants with a history of severe allergic reactions to antibiotics, those unable to comply with study procedures, or infants with liver or kidney disease.
Treatment approach: Aztreonam kills bacteria by stopping their growth, avibactam enhances aztreonam’s effectiveness by preventing bacteria from breaking it down, and metronidazole treats certain bacterial and parasitic infections. The medications are given through intravenous infusion, with close monitoring of the infant’s health, including liver and kidney functions, blood medication levels, and any side effects throughout the treatment period.
Summary
These 15 clinical trials represent a comprehensive effort to improve treatment options for urinary tract infections across various patient populations and infection types. Several notable patterns emerge from this collection of studies.
A significant focus is placed on pediatric populations, with multiple trials investigating treatments specifically for children, ranging from newborns to adolescents. This includes studies examining meropenem-vaborbactam, aztreonam-avibactam, and cefepime-enmetazobactam combinations in young patients with complicated infections.
Another major theme is addressing antibiotic resistance, particularly infections caused by ESBL-producing bacteria, carbapenem-resistant Enterobacterales, and multidrug-resistant organisms. Several trials explore novel antibiotic combinations that include beta-lactamase inhibitors like nacubactam, vaborbactam, and avibactam, which help overcome bacterial resistance mechanisms.
Eastern European countries show substantial participation, with multiple trials conducted in Spain, Slovakia, Czechia, Poland, and Hungary. This geographic distribution suggests strong research infrastructure in these regions for infectious disease studies.
The trials also reflect diverse therapeutic approaches, including traditional antibiotics, combination therapies, preventive vaccines, and even innovative strategies like fecal microbiota transfer. Some studies focus on optimizing treatment duration, comparing shorter courses with traditional longer regimens to potentially reduce antibiotic exposure while maintaining effectiveness.
Several trials specifically target vulnerable or specialized populations, including patients with neurogenic bladder due to spinal cord injury, premenopausal women with recurrent infections, and hospitalized adults with resistant bacterial infections. This demonstrates the research community’s recognition that different patient groups may require tailored treatment approaches.






