Ongoing Clinical Trials for Bacterial Infections
This article provides information about 16 ongoing clinical trials investigating treatments for various bacterial infections. These studies are testing different antibiotics and treatment approaches in patients ranging from newborns to adults, with trials taking place across multiple European countries including Spain, France, Denmark, Netherlands, Sweden, Germany, Finland, Hungary, Slovakia, Italy, Bulgaria, Greece, and Czechia.
Clinical trial locations
- Bulgaria
- Czechia
- Denmark
- Study on Reducing Infections After Bladder Removal Surgery Using Pivmecillinam Hydrochloride and Other Antibiotics for Patients Undergoing Ureteral Stent Removal
- Study on Shortened Antibiotic Treatment for Gram-negative Bacteremia in Hospitalized Adults Using Pivmecillinam Hydrochloride and Drug Combination
- Finland
- France
- Study on Piperacillin-Tazobactam and Temocillin for Treating Severe Infections in ICU Patients with ESBL-Producing Gram-Negative Bacteria
- Study of Oral Fecal Microbiota Transplantation in Patients Colonized with Multi-Drug Resistant Bacteria
- Study on Amikacin for Treating Mycobacterium Xenopi Lung Infection in Patients Using Amikacin and Drug Combination
- Germany
- Greece
- 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 Cefiderocol for Treating Gram-negative Bacterial Infections in Hospitalized Infants Under 3 Months
- 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 the Effectiveness and Safety of Extended vs. Intermittent Infusion of Meropenem in Critically Ill Children with Suspected or Proven Infection
- Italy
- See more trials
Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
This study 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.
Who can participate: Children must be hospitalized and have a suspected or confirmed serious infection such as complicated intra-abdominal infection, complicated urinary tract infection, hospital-acquired pneumonia, ventilator-associated pneumonia, or bloodstream infection. These infections must be caused by gram-negative bacteria and require treatment with intravenous antibiotics. 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 medication, current participation in another clinical trial, medical conditions that would make participation unsafe, pregnancy or breastfeeding, history of drug or alcohol abuse, or conditions affecting their ability to follow study instructions are excluded.
What the study involves: The trial compares aztreonam-avibactam plus metronidazole against the best available therapy. Aztreonam-avibactam is given through an intravenous infusion, with dosage and frequency determined by the study team. Throughout the study, participants’ health is closely monitored, including regular assessments of liver and kidney functions and checks for side effects. Blood samples are taken to measure medication levels in the blood. At the end of treatment, clinical outcomes are evaluated and microbiological tests are conducted to assess bacterial response.
Medications being tested: Aztreonam-Avibactam is a combination antibiotic where aztreonam kills bacteria while avibactam prevents bacteria from breaking down aztreonam. Metronidazole is used alongside to help treat complicated abdominal infections by stopping the growth of bacteria and parasites.
Study on Piperacillin-Tazobactam and Temocillin for Treating Severe Infections in ICU Patients with ESBL-Producing Gram-Negative Bacteria
This trial is evaluating whether piperacillin-tazobactam and temocillin can be effective alternatives to carbapenem antibiotics for treating severe infections in intensive care unit patients.
Who can participate: Patients must be 18 years or older, hospitalized in the ICU with a severe infection confirmed within 24 hours. The infection must be caused by ESBL-producing Enterobacteriaceae bacteria that are treatable with meropenem and either piperacillin-tazobactam or temocillin. Signed informed consent from the patient or legal representative is required, or emergency inclusion may proceed with consent sought as soon as possible. Patients must be affiliated with social security.
Who cannot participate: Patients not in the ICU, those without severe ESBL-producing Enterobacteriaceae infections, and those not within the specified age range cannot participate.
What the study involves: After eligibility is confirmed, patients are randomly assigned to receive either meropenem, piperacillin-tazobactam, or temocillin. The medication is administered through infusion directly into the bloodstream. Throughout treatment, health is closely monitored for side effects and treatment effectiveness. Follow-up evaluations occur at 30 and 90 days to assess outcomes, including any infection relapse or complications.
Medications being tested: Piperacillin-tazobactam is a combination antibiotic that stops bacterial growth. Temocillin is another antibiotic being tested as an alternative to carbapenems for treating infections caused by resistant bacteria.
Study on Reducing Infections After Bladder Removal Surgery Using Pivmecillinam Hydrochloride and Other Antibiotics for Patients Undergoing Ureteral Stent Removal
This study aims to reduce infection-related hospital readmissions after bladder removal surgery by comparing targeted antibiotic prophylaxis to standard antibiotic prophylaxis during ureteral stent removal.
Who can participate: Patients must be at least 18 years old, able to understand and sign informed consent, undergoing cystectomy for either cancerous or non-cancerous reasons, and have a planned ileal conduit procedure.
Who cannot participate: Patients with any bacterial infection, those not within the specified age range, and those who are part of a vulnerable population are excluded.
What the study involves: Upon joining, participants provide informed consent and must meet eligibility criteria. During ureteral stent removal, patients receive either standard antibiotic treatment or targeted antibiotic prophylaxis. Medications are given orally and include pivmecillinam hydrochloride, trimethoprim, fluconazole, amoxicillin, ciprofloxacin, sulfamethoxazole with trimethoprim, amoxicillin with clavulanic acid, cefuroxime axetil, nitrofurantoin, or linezolid. Follow-up assessments monitor health and check for infections at 30 and 90 days after surgery.
Medications being tested: Targeted Antibiotic Prophylaxis uses specific antibiotics chosen based on individual patient needs and bacteria present. Empiric Antibiotic Prophylaxis uses broad-spectrum antibiotics based on general guidelines.
Study on Shortened Antibiotic Treatment for Gram-negative Bacteremia in Hospitalized Adults Using Pivmecillinam Hydrochloride and Drug Combination
This trial compares the effectiveness and safety of a 5-day antibiotic course versus the traditional 7-day or longer treatment for gram-negative bacteremia originating from urinary tract infections.
Who can participate: Patients must be over 18 years old with a positive blood test showing gram-negative bacteria and signs of urinary tract infection. They must have started appropriate antibiotic treatment within 12 hours of the first positive blood test. At enrollment, patients must have body temperature below 37.8°C, blood pressure higher than 90 mm Hg, heart rate less than 100 beats per minute, breathing rate less than 24 breaths per minute, and oxygen level above 90%. Both oral and written consent are required.
Who cannot participate: Patients under 18, those with weakened immune systems, and those part of vulnerable populations are excluded.
What the study involves: After confirming eligibility, antibiotic treatment begins within 12 hours of the first positive blood culture. Vital signs are monitored to ensure stability. Participants are randomly assigned to receive either a 5-day or longer antibiotic course. Medications include Selexid, Ciprofloxacin, Bioclavid, and others, administered orally or through injection. Participants are monitored for 90 days to assess survival, adverse events, and treatment effectiveness.
Medications being tested: The study tests various antibiotics to determine if a shorter 5-day treatment is as effective and safe as the longer traditional treatment for gram-negative bacteremia.
A Study of Ciprofloxacin and Vancomycin Effects in Patients Carrying Antibiotic-Resistant Bacteria (ESBL and VRE)
This study examines how antibiotic treatment affects people who carry antibiotic-resistant bacteria called VRE and ESBL-producing bacteria in their digestive system.
Who can participate: Participants must be at least 18 years old and provide signed informed consent. They must have confirmed presence of VRE or EPE in previous screening or clinical culture, with a negative result in the most recent screening. For EPE carriers, the bacterial strain must be resistant to ciprofloxacin. Women who can become pregnant must use adequate contraception. Both men and women can participate.
Who cannot participate: People with known allergy to study medications, pregnant or breastfeeding women, those who participated in another clinical trial within 30 days, history of severe kidney disease, current use of interacting medications, active infection requiring immediate treatment, inability to follow study procedures, colonization with bacteria other than VRE or ESBL, severe liver disease, recent major surgery, compromised immune system, or mental conditions affecting informed consent are excluded.
What the study involves: After confirming carrier status and negative screening, participants receive either ciprofloxacin or vancomycin by mouth. Stool samples are collected to check for resistant bacteria and analyze intestinal bacteria composition. The study monitors bacterial status changes and tracks the time required for bacterial status to return to normal.
Medications being tested: The study examines how antibiotics affect both normal gut bacteria and resistant bacteria in carriers, though specific antibiotics are not detailed in the source data.
Study Comparing 7-Day and 14-Day Treatment with Vancomycin, Linezolid, and Daptomycin for Patients with Uncomplicated Enterococcal Blood Infections
This trial compares the safety and effectiveness of 7-day versus 14-day antibiotic treatment for uncomplicated bacteremia caused by Enterococcus bacteria.
Who can participate: Adult patients 18 years or older hospitalized with uncomplicated bacteremia caused by E. faecalis or E. faecium. Patients must have negative blood culture results between days 2-3 of treatment, fever that disappears within the first 72 hours of treatment, and provide signed informed consent.
Who cannot participate: Patients with infections not caused by E. faecalis or E. faecium, complicated infections, inability to take antibiotics, current participation in another trial, known allergy to study antibiotics, pregnancy or breastfeeding, severe liver or kidney disease, weakened immune system, recent or planned surgery, or inability to follow study procedures are excluded.
What the study involves: After providing consent and confirming eligibility, treatment begins with antibiotics administered intravenously or orally. Medications include vancomycin, linezolid, piperacillin with tazobactam, clavulanic acid, daptomycin, ampicillin, and amoxicillin. Within the first 72 hours, fever should disappear and blood cultures are performed. Treatment lasts either 7 or 14 days depending on group assignment. Follow-up visits monitor for relapse or secondary infections.
Medications being tested: The study tests whether a shorter 7-day antibiotic treatment provides the same benefits as the traditional 14-day treatment for uncomplicated enterococcal bacteremia.
Study Comparing Norfloxacin and Conventional Antibiotics for Hospitalized Patients with Decompensated Cirrhosis and Bacterial Infections
This study compares conventional antibiotic strategies with treatment guided by hospital bacteria monitoring for patients with decompensated cirrhosis and bacterial infections.
Who can participate: Patients must have cirrhosis with acute decompensation, be 18 years or older, have proven or suspected bacterial infection requiring antibiotics, and provide signed informed consent from themselves or legal representatives.
Who cannot participate: Patients not hospitalized with decompensated cirrhosis, those without bacterial infection present for 48 hours or less, those not within the specified age range or clinical trial group, and those not part of the selected vulnerable population are excluded.
What the study involves: After signing informed consent, an initial assessment confirms decompensated cirrhosis and bacterial infection within 48 hours. Participants are randomly assigned to conventional treatment or epidemiologically-guided treatment. Norfloxacino Sandoz 400 mg tablets are administered orally. Monitoring occurs over 28 days for antibiotic resistance development, infection resolution, health score changes, and need for intensive care.
Medications being tested: Conventional Antibiotic Strategies use standard treatments based on common practices. Regimens Guided by Epidemiological Surveillance use antibiotics selected based on specific bacterial data in the environment.
Study of Oral Fecal Microbiota Transplantation in Patients Colonized with Multi-Drug Resistant Bacteria
This study investigates whether fecal microbiota transplant can remove multidrug-resistant gram-negative bacteria from the digestive system.
Who can participate: Patients aged 18-105 years with at least one positive rectal swab showing ESBL-E or CRE bacteria or history of infection with these bacteria within the past year. Participants must be able to swallow 50 capsules in one day without swallowing difficulties. Potential donors must be 18-50 years old with body mass index below 30 and regular bowel movements. Both men and women can participate.
Who cannot participate: People under 18 or over 65 years, those with current active infection requiring antibiotics, history of severe allergic reactions, pregnancy or breastfeeding, participation in other trials, inability to swallow capsules, recent antibiotic treatment, severe immunodeficiency, active gastrointestinal disease, recent hospitalization, history of Clostridium difficile infection in past 6 months, use of immune-suppressing medications, uncontrolled chronic conditions, mental conditions affecting study compliance, or history of drug/alcohol abuse are excluded.
What the study involves: Participants receive 50 oral capsules in a single day containing either fecal microbiota transplant or placebo. Health status is monitored for 30 days with rectal swab tests to determine bacterial presence. Final evaluation determines if treatment successfully removed resistant bacteria.
Medications being tested: Fecal Microbiota Transplant uses processed stool from healthy donors in frozen capsule form to restore healthy gut bacteria and fight antibiotic-resistant bacteria.
Study of Temocillin and Meropenem for Patients with Infections Caused by Resistant Enterobacteriaceae
This study examines whether temocillin is as effective as meropenem in treating infections caused by Enterobacteriaceae resistant to third-generation cephalosporins.
Who can participate: Hospitalized adult patients 18 years or older with bacteremia caused by Enterobacterales bacteria. The infection can involve more than one type of bacteria, with at least one resistant to third-generation cephalosporins. The bacteria must be sensitive to both temocillin and meropenem. Patients must need intravenous treatment for at least 4 days (or 3 days if already receiving appropriate treatment), provide signed informed consent, and have negative pregnancy test if applicable.
Who cannot participate: Patients with allergies to study medications, severe liver or kidney problems, pregnant or breastfeeding women, current participation in another trial, history of drug or alcohol abuse, certain heart conditions, compromised immune system, children under 18, recent major surgery, or history of certain cancers are excluded.
What the study involves: After confirming eligibility and obtaining consent, patients are randomly assigned to receive either temocillin or meropenem intravenously. Treatment lasts at least 4 days (or 3 days with prior appropriate treatment) and should not exceed 14 days unless necessary. Patients are monitored for clinical success including survival at day 28, no need to change medication due to adverse events, and no infection recurrence. Follow-up assessments continue up to day 28.
Medications being tested: Temocillin and Meropenem are both antibiotics being compared for effectiveness and safety in treating bloodstream infections caused by resistant bacteria.
Study on Adjusted Ciprofloxacin Dosing for Patients with Kidney Impairment and Bacterial Infections
This trial compares different ciprofloxacin doses in patients with impaired kidney function versus those with normal kidney function to ensure similar drug exposure.
Who can participate: Patients must be receiving ciprofloxacin treatment either intravenously or orally as standard care, be at least 18 years old, admitted to general wards of specific hospitals, and provide informed consent.
Who cannot participate: Patients with bacterial infections, those with severely impaired kidney function (eGFR less than 30 ml/min/1.73m²), those not within the specified age range, and those part of vulnerable populations are excluded.
What the study involves: After providing consent and confirming eligibility, treatment begins with ciprofloxacin. Patients with impaired kidney function receive revised lower doses: 750 mg orally once daily or 600 mg intravenously once daily. Patients with normal kidney function receive regular doses: 500 mg orally twice daily or 400 mg intravenously twice daily. Drug exposure is monitored during the first 24 hours of treatment.
Medications being tested: Ciprofloxacin is an antibiotic being tested at different dosing regimens to determine if patients with kidney impairment receive effective and safe doses.
Summary
The 16 ongoing clinical trials described in this article reflect a diverse approach to addressing bacterial infections across different patient populations and geographical locations. Several notable patterns emerge from this collection of studies.
Spain stands out as the most active country in bacterial infection research, hosting five trials. France follows with three studies, while multiple other European countries contribute one or two trials each. This geographic distribution demonstrates widespread European commitment to improving bacterial infection treatment.
A significant focus appears on pediatric populations, with multiple trials specifically targeting newborns, infants, and children. Studies such as those testing aztreonam-avibactam combinations in very young patients address the critical need for effective treatments in vulnerable populations where treatment options are often limited.
Antibiotic resistance emerges as a central theme throughout these trials. Many studies specifically target multidrug-resistant bacteria, including ESBL-producing Enterobacteriaceae, carbapenem-resistant bacteria, and vancomycin-resistant enterococci. This emphasis reflects the growing global concern about antibiotic resistance and the urgent need for effective treatment strategies.
Several trials investigate innovative approaches beyond traditional antibiotics. Fecal microbiota transplantation appears in two studies as a novel method to eliminate resistant bacteria from the digestive system. This represents a significant shift toward microbiome-based therapies for managing bacterial colonization and infection.
Treatment duration optimization is another important theme, with multiple studies comparing shorter versus longer antibiotic courses. These trials seek to balance treatment effectiveness with the need to minimize antibiotic exposure, reduce side effects, and combat resistance development.
The trials also demonstrate attention to optimizing antibiotic delivery methods, such as comparing extended versus intermittent infusions and adjusting doses for patients with kidney impairment. These studies aim to ensure medications reach effective levels in the bloodstream while maintaining safety.
Specialized patient populations receive focused attention, including intensive care unit patients, those with cirrhosis, healthcare workers, and patients undergoing specific surgical procedures. This targeted approach acknowledges that different patient groups may require tailored treatment strategies.
These ongoing trials collectively represent an important effort to improve bacterial infection treatment through rigorous scientific investigation, offering hope for better outcomes and addressing the critical challenge of antibiotic resistance.
