Ongoing Clinical Trials for Bacterial Pneumonia
There are currently 6 clinical trials investigating new treatments for bacterial pneumonia across Europe. These studies are exploring various approaches including high-dose antibiotic regimens, bacteriophage therapies, inhaled medications, and combination treatments specifically designed for critically ill patients in intensive care units.
Clinical trial locations
- Belgium
- Croatia
- Czechia
- Espagne
- France
- Study on Nebulized Amikacin for Treating Ventilator-Associated Gram-Negative Pneumonia in Patients on Veno-Arterial ECMO
- Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections
- Study on the Effectiveness and Safety of Imipenem, Cilastatin, and XNW4107 for Adults with Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
- Greece
- Latvia
- Netherlands
- Portugal
- Slovakia
- Spain
- Study on Preventing Early Respiratory Infections in Intubated Patients Using Ceftriaxone, a Cough Simulator, and Subglottic Secretion Aspiration
- Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections
- Study on the Effectiveness and Safety of Imipenem, Cilastatin, and XNW4107 for Adults with Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Study on High-Dose Short-Course Antibiotics for Critically Ill Patients with Pneumonia, Intra-Abdominal, or Bloodstream Infections: Ceftriaxone, Linezolid, and Cefotaxime
This trial is investigating whether a shorter course of high-dose antibiotics can be as effective as conventional treatment for critically ill patients. The study focuses on patients in intensive care units who have community-acquired pneumonia, hospital-acquired pneumonia, ventilator-acquired pneumonia, intra-abdominal infections, or bloodstream infections.
Inclusion criteria: Participants must be at least 18 years old and admitted to an ICU with an expected stay of at least two more days. They must have or be suspected of having one of the targeted infections and be receiving treatment with specific antibiotics including ceftriaxone, cefotaxime, cefuroxime, piperacillin-tazobactam, or meropenem. Patients must also have experienced recent organ problems such as low blood pressure requiring medication, need for breathing support, or reduced kidney function.
Exclusion criteria: Patients with certain serious infections requiring longer treatment courses, such as heart valve infections, specific types of blood infections with Staphylococcus aureus, or bone infections cannot participate. The trial is limited to male and female participants within the specified age range.
Trial focus: The main goal is to determine if a shorter, high-dose antibiotic treatment can achieve similar survival rates over 90 days compared to standard treatment while reducing overall antibiotic exposure. This approach could help prevent antibiotic resistance and improve outcomes for critically ill patients.
Investigational drugs: The trial uses several antimicrobial medications administered intravenously, comparing high-dose short courses with conventional dosing regimens of antibiotics commonly used to treat severe bacterial infections.
Safety and tolerability study of bacteriophage cocktail TP-122A given by inhalation in adults with ventilator-associated pneumonia
This innovative trial is testing a bacteriophage treatment for ventilator-associated pneumonia, which is a lung infection that develops in patients on breathing machines. Bacteriophages are naturally occurring viruses that specifically target and kill harmful bacteria.
Inclusion criteria: Participants must be at least 18 years old and receiving mechanical ventilation in intensive care for at least 48 hours with specific oxygen and lung function requirements. They must have new signs of lung infection visible on chest imaging within the last 24 hours and show breathing problems with fever or other infection signs. A confirmed Pseudomonas aeruginosa infection in the lungs through laboratory testing is required, and women of childbearing age must have a negative pregnancy test.
Exclusion criteria: People with known allergies to study components, active lung diseases other than ventilator-associated pneumonia such as severe asthma or COPD, severe kidney or liver problems, pregnancy or breastfeeding, participation in another trial within 30 days, history of severe allergic reactions, life-threatening conditions unrelated to the pneumonia, planned major surgery, organ transplantation history, active cancer requiring treatment, or severe heart conditions cannot participate.
Trial focus: The study evaluates the safety and tolerability of TP-122A, a bacteriophage cocktail given through inhalation every 8 hours for 7 days alongside standard care. Researchers will monitor patients’ recovery, vital signs, blood work, heart function, and time spent on ventilation and in intensive care.
Investigational drugs: TP-122A is a bacteriophage cocktail administered through nebulization that targets specific bacteria like Pseudomonas aeruginosa and Klebsiella pneumoniae. This treatment represents an alternative approach to traditional antibiotics.
Study on Nebulized Amikacin for Treating Ventilator-Associated Gram-Negative Pneumonia in Patients on Veno-Arterial ECMO
This trial examines whether adding inhaled amikacin to standard antibiotic treatment can more effectively clear lung infections in patients receiving a specialized life support system called veno-arterial ECMO.
Inclusion criteria: Participants must be at least 18 years old and receiving veno-arterial ECMO support for at least 24 hours before pneumonia confirmation. They must be on invasive mechanical ventilation with suspected pneumonia based on fever, changes in white blood cell counts, thick lung secretions, oxygen level changes, or specific imaging findings. Microbiological confirmation of gram-negative bacterial pneumonia through lung sample testing is required, and patients must be receiving piperacillin-tazobactam antibiotic therapy. Informed consent from the patient or a trusted representative is necessary, and participants must be affiliated with a social security scheme.
Exclusion criteria: Anyone under 18 years old, not receiving ECMO support, without gram-negative bacterial pneumonia, not on mechanical ventilation, or not receiving veno-arterial ECMO cannot participate.
Trial focus: The study aims to determine if adding inhaled amikacin for five days can improve bacterial clearance rates compared to standard treatment alone. Researchers will monitor infection status, side effects, and how well the medications work in the body throughout the treatment period.
Investigational drugs: Amikacin sulfate is administered as an inhaled mist in addition to standard intravenous piperacillin-tazobactam treatment. This approach delivers the antibiotic directly to the lungs to fight the infection.
Study on Preventing Early Respiratory Infections in Intubated Patients Using Ceftriaxone, a Cough Simulator, and Subglottic Secretion Aspiration
This prevention-focused trial investigates multiple approaches to prevent respiratory infections in patients with reduced consciousness who require breathing tubes due to severe trauma, brain injury, stroke, or cardiac arrest.
Inclusion criteria: Participants must be older than 17 years with a breathing tube expected to remain in place for more than 48 hours. They must have one of the following conditions: severe trauma or head trauma, ischemic or hemorrhagic stroke, successful resuscitation after cardiac arrest, central nervous system intoxications, or status epilepticus.
Exclusion criteria: Patients with reduced consciousness from causes other than those specified, or those not meeting the age and intubation requirements cannot participate.
Trial focus: The study compares the safety and effectiveness of combining short-course ceftriaxone antibiotic therapy, a bionic cough simulator device, and subglottic secretion aspiration method in preventing respiratory infections. Researchers will monitor for severe adverse events and infection occurrence during the first 14 days, along with intubation duration, ICU stay length, and overall patient recovery.
Investigational drugs: Ceftriaxone is administered intravenously as a preventive antibiotic. The trial also employs a cough simulator device to clear airway secretions and subglottic aspiration therapy to remove throat secretions that could cause infections.
Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections
This international trial addresses the challenging problem of antibiotic-resistant bacteria, specifically carbapenem-resistant Enterobacterales, which cause difficult-to-treat infections including hospital-acquired and ventilator-associated pneumonia.
Inclusion criteria: Participants must be at least 18 years old and weigh 140 kg or less. They must be able to remain hospitalized during treatment and have either confirmed or suspected carbapenem-resistant bacterial infection. For confirmed infections, laboratory testing must be completed within 72 hours (or 96 hours for certain infections) before starting study medication, with either no more than 24 hours of appropriate antibiotic treatment or signs of treatment failure after at least 48 hours. For suspected infections, evidence from tests or previous records within 90 days is required along with similar treatment criteria.
Exclusion criteria: People with allergies to study medications or similar antibiotics, kidney problems requiring dialysis, significant liver disease, pregnancy or breastfeeding, current participation in another trial, drug or alcohol abuse history that might interfere with the study, weakened immune systems, certain non-target infections, recent use of specific antibiotics, or significant blood test abnormalities cannot participate.
Trial focus: The trial compares two antibiotic combination treatments against current best available therapy for treating complicated urinary tract infections, kidney infections, hospital-acquired pneumonia, ventilator-associated pneumonia, and complicated intra-abdominal infections. Treatment is given intravenously for up to 14 days with close monitoring of treatment success and safety.
Investigational drugs: Cefepime/nacubactam combines an antibiotic with a substance that helps overcome bacterial resistance. Aztreonam/nacubactam offers a similar approach with a different antibiotic. Nacubactam enhances effectiveness by blocking enzymes bacteria use to resist treatment.
Study on the Effectiveness and Safety of Imipenem, Cilastatin, and XNW4107 for Adults with Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
This trial investigates new treatment combinations for serious lung infections that occur during hospital stays, particularly focusing on infections caused by gram-negative bacteria.
Inclusion criteria: Participants must be at least 18 years old with hospital-acquired or ventilator-associated pneumonia requiring intravenous antibiotic therapy. Hospital-acquired pneumonia must occur at least 48 hours after hospitalization or within 7 days after discharge, while ventilator-associated pneumonia occurs in patients on mechanical ventilation for at least 48 hours. Patients must have new or worsening respiratory symptoms, fever or temperature abnormalities, white blood cell count changes, and chest imaging showing new or worsening lung infiltrates. A suspected gram-negative bacterial infection confirmed by laboratory tests is required. Participants must agree to provide bacterial samples for study testing and use highly effective birth control methods during and after the study.
Exclusion criteria: People with known allergies to study drugs, participation in another trial, severe liver or kidney disease, pregnancy or breastfeeding, drug or alcohol abuse within the past year, recent use of certain antibiotics, infections caused by bacteria not sensitive to study drugs, history of seizures or epilepsy, or conditions that would make participation unsafe cannot join the study.
Trial focus: The study compares imipenem/cilastatin combined with XNW4107 against imipenem/cilastatin/relebactam to evaluate overall survival rates. Treatments are administered intravenously for up to 14 days with close health monitoring. The main goal is to determine which treatment is more effective in reducing mortality by day 14, with additional assessment at day 28.
Investigational drugs: Imipenem/cilastatin-XNW4107 combines an antibiotic that kills bacteria by interfering with their cell walls with cilastatin, which prevents the antibiotic’s breakdown in the kidneys. XNW4107 may enhance this combination’s effectiveness. The comparison treatment, imipenem/cilastatin/relebactam, adds relebactam to help overcome bacterial resistance mechanisms.
Summary
The six ongoing trials for bacterial pneumonia reflect the urgent need for new treatment approaches for critically ill patients, particularly those in intensive care units on mechanical ventilation. A notable concentration of research is occurring in France and Spain, with multiple trials running in these countries. The studies collectively address several key challenges in treating severe lung infections: antibiotic resistance, optimal dosing strategies, and prevention of hospital-acquired infections.
Several trials focus specifically on ventilator-associated pneumonia, recognizing this as a significant complication in intensive care settings. The research encompasses diverse approaches, from traditional antibiotic combinations enhanced with resistance-breaking agents to innovative bacteriophage therapy. Multiple studies are investigating treatments for carbapenem-resistant bacteria, highlighting the growing concern about antibiotic-resistant infections in hospitals.
The trials employ various administration methods including intravenous infusions and inhaled medications, with some studies comparing high-dose short-course treatments against conventional regimens. One particularly innovative trial is testing bacteriophage therapy, representing a potential alternative to traditional antibiotics. The geographic distribution shows strong European collaboration, with trials spanning from Portugal to Latvia and involving multiple countries in coordinated research efforts.
