Ongoing Clinical Trials for Infection
There are currently 3 ongoing clinical trials investigating different treatments for various types of infections. These studies are being conducted across multiple European countries and focus on preventing and treating bacterial infections in different patient populations, including children with serious gram-negative infections, women undergoing breast reconstruction surgery, and critically ill adults requiring intensive care treatment.
Clinical trial locations
- Czechia
- Denmark
- Estonia
- Greece
- Hungary
- Spain
Study of Aztreonam-Avibactam and Metronidazole for Children with Serious Gram-Negative Bacterial Infections
This trial is investigating a combination treatment for children aged 9 months to less than 18 years who have serious bacterial infections caused by gram-negative bacteria. The study focuses on treating conditions such as complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired pneumonia, ventilator-associated pneumonia, and bloodstream infections.
Inclusion criteria: Children must be between 9 months and less than 18 years old at the time of screening. They must have a suspected or confirmed serious infection, including complicated intra-abdominal infection (a serious infection inside the belly area), complicated urinary tract infection (a serious infection in the urinary system), hospital-acquired or ventilator-associated pneumonia (lung infections acquired in a hospital setting), or bloodstream infection. The infections must be caused by gram-negative bacteria, and participants must require hospitalization and treatment with intravenous antibiotics, meaning they need medicine delivered directly into a vein. Female participants who have started menstruating must have a negative pregnancy test.
Exclusion criteria: Children cannot participate if they have other serious infections unrelated to the study, known allergies to the study medications or their components, or are currently participating in another clinical trial. They should not have medical conditions that study doctors believe would make it unsafe to participate. Participants must not be pregnant or breastfeeding, have a history of drug or alcohol abuse that could interfere with the study, or have any condition affecting their ability to understand or follow study instructions.
Focus and goals: The trial aims to evaluate the safety and effectiveness of aztreonam-avibactam in combination with metronidazole compared to the best available therapy. Participants will be assigned to one of two groups: one receiving the combination treatment and the other receiving standard care. The treatment is given through intravenous infusion, with dosage and frequency determined based on individual needs. Throughout the study, health will be closely monitored, including regular assessments of liver and kidney function and checking for side effects. Blood samples will be taken to measure medication levels. At the end of treatment, clinical outcomes and microbiological response will be evaluated, with follow-up monitoring to ensure recovery.
Investigational drugs: Aztreonam-Avibactam is a combination medication where Aztreonam is an antibiotic that kills bacteria, and Avibactam helps prevent bacteria from breaking down Aztreonam, making the treatment more effective. This combination is given through a vein and targets bacteria that are difficult to treat with other antibiotics. Metronidazole is an antibiotic that stops the growth of bacteria and parasites. In this trial, it is used alongside Aztreonam-Avibactam to help treat complicated infections in the abdomen.
Title: Study of gentamicin, vancomycin and cefazolin antibiotics to prevent infections in women having breast reconstruction surgery with implants
This study focuses on preventing infections in women undergoing breast reconstruction surgery with implants. The research evaluates whether applying a combination of three antibiotics directly to the surgical area during the procedure can reduce the risk of infection and complications that might lead to implant removal.
Inclusion criteria: Participants must be at least 18 years old, biologically female, and provide signed informed consent. They must be scheduled for breast reconstruction surgery using implants or tissue expanders, including immediate reconstruction (performed at the same time as breast removal), delayed reconstruction (performed some time after breast removal), surgery on one or both breasts, and reconstruction with or without additional tissue from another part of the body.
Exclusion criteria: Women cannot participate if they have a known allergy or hypersensitivity to gentamicin, vancomycin, or cefazolin, have an active infection at the time of surgery, are pregnant or breastfeeding, or have a history of previous breast reconstruction surgery with complications. Other exclusions include severe immune system disorders, current participation in other clinical trials, inability to provide informed consent, chronic medical conditions that are not well controlled (such as diabetes or heart disease), history of adverse reactions to breast implants, previous radiation therapy to the chest area, blood clotting disorders, mental health conditions that might interfere with study procedures, inability to attend follow-up appointments, or systemic antibiotic treatment within 2 weeks before surgery.
Focus and goals: The trial aims to determine if using antibiotics locally during surgery can prevent infections and complications. During the surgery, the breast implant or expander is treated with a special antibiotic solution containing gentamicin, vancomycin, and cefazolin mixed with saline solution. The antibiotics are applied directly to the implant surface before placement. Recovery is monitored for the first 180 days (6 months) after surgery, with medical staff checking for signs of surgical site infection, evaluating the condition of the breast implant, and assessing any need for additional procedures. Monitoring continues for up to one year, with a final evaluation conducted to assess the overall success of the reconstruction and document any complications.
Investigational drugs: Gentamicin is an antibiotic applied locally to the breast implant area during surgery to help reduce the risk of post-surgical infections. Vancomycin is a powerful antibiotic used as part of the combination treatment to prevent serious bacterial infections. Cefazolin is an antibiotic commonly used to prevent infections during and after surgery. The three antibiotics are used together as a preventive solution applied directly to breast implants during reconstructive surgery to protect against bacterial infections that could lead to implant loss.
Study on Vancomycin Hydrochloride for Treating Serious Infections in Critically Ill Adults Using a Precision Dosing Tool
This clinical trial focuses on treating serious infections in critically ill adults using vancomycin hydrochloride. The study evaluates a new tool that helps doctors determine the best dose of vancomycin to ensure patients receive the right amount of medication during treatment, with the goal of improving effectiveness and reducing side effects.
Inclusion criteria: Participants must be at least 18 years old and admitted to a tertiary intensive care unit, which is a specialized hospital unit for patients who need intensive medical care. They must have a medical condition that requires treatment with intravenous vancomycin, as decided by their doctor.
Exclusion criteria: Patients with serious infections that require treatment with intravenous vancomycin cannot participate in the study.
Focus and goals: The trial uses a special tool to help doctors adjust the dose of vancomycin to keep it within a target range for at least 70% of the treatment period. Upon joining the study, participants are assessed to ensure they meet criteria. Treatment begins with vancomycin hydrochloride administered through an infusion directly into the bloodstream, with dosage and frequency determined using the precision dosing tool. Throughout treatment, response to vancomycin is closely monitored, with adjustments made to maintain medication within the target range. Progress is evaluated regularly, including checks during the first 24 to 48 hours and throughout the treatment period. The length of treatment depends on individual response and medical condition. At the end of the study, health status is reviewed, including checks for side effects such as kidney issues and determining the patient’s condition at discharge.
Investigational drug: Vancomycin is an antibiotic used to treat serious infections caused by bacteria. The trial focuses on using a precision dosing tool to help doctors give the right amount of vancomycin to ensure the medicine works well for more than 70% of the treatment time while reducing the risk of side effects. Vancomycin works by inhibiting the formation of bacterial cell walls, which are essential for bacteria to survive and multiply. It belongs to the class of glycopeptide antibiotics and is particularly effective against serious infections caused by Gram-positive bacteria, especially those resistant to other antibiotics.
Summary
These three ongoing clinical trials represent diverse approaches to managing bacterial infections across different patient populations and clinical settings. The studies are being conducted in six European countries: Spain, Hungary, Greece, Czechia, Denmark, and Estonia.
A notable feature of these trials is their focus on optimizing antibiotic use. The pediatric study in four countries evaluates aztreonam-avibactam combination therapy for serious gram-negative bacterial infections in children, addressing the challenge of treating antibiotic-resistant bacteria in young patients. The Danish trial takes a preventive approach, investigating whether local application of a three-antibiotic combination during breast reconstruction surgery can reduce post-surgical infections. The Estonian study focuses on precision medicine by evaluating a dosing tool to optimize vancomycin treatment in critically ill adults.
The trials also reflect different therapeutic strategies: treating existing serious infections in children and critically ill adults, versus preventing infections during surgical procedures. This variety demonstrates ongoing efforts to improve both treatment effectiveness and prevention strategies across different medical specialties and patient age groups.
