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Study on the Effectiveness and Safety of Imipenem, Cilastatin, and XNW4107 for Adults with Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, which are types of lung infections that occur in patients during or after a hospital stay. These infections are often caused by a group of bacteria known as Gram-negative bacteria. The study will compare the effectiveness and safety of two different treatments. One treatment involves a combination of medications called Imipenem and Cilastatin with a new investigational drug known as XNW4107. The other treatment combines Imipenem, Cilastatin, and another drug called Relebactam, which is already used in medical practice.

The purpose of the study is to evaluate the overall survival rate of patients receiving these treatments. Participants in the study will be randomly assigned to receive one of the two treatments. The medications will be given through an intravenous infusion, which means they will be administered directly into a vein. The study will last for a period of up to 14 days, during which the health of the participants will be closely monitored by medical professionals. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments.

Throughout the study, participants will undergo regular health assessments to track their progress and any changes in their condition. The main goal is to determine which treatment is more effective in reducing the mortality rate by the 14th day after starting the treatment. The study will also look at the mortality rate on the 28th day and assess the success of the treatments in clearing the infection. This research aims to provide valuable information that could improve the treatment of these serious lung infections in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization
Upon joining the study, you will be randomly assigned to one of two groups. This means you will either receive the imipenem/cilastatin-XNW4107 treatment or the imipenem/cilastatin/relebactam treatment. This process is done by chance, like flipping a coin, to ensure fairness and objectivity in the study.
Step 2
Treatment administration
You will receive the assigned medication through an intravenous infusion. This means the medication will be given directly into your vein using a needle. The specific dosage and frequency will be determined by the study team based on the treatment group you are in.
Step 3
Monitoring and assessments
Throughout the study, your health will be closely monitored. This includes regular check-ups and assessments to evaluate your response to the treatment. The study team will conduct various tests and collect data to ensure your safety and to measure the effectiveness of the treatment.
Step 4
Follow-up visits
After completing the treatment phase, you will have follow-up visits. These visits are important to check on your health and to gather additional information about the long-term effects of the treatment. The study team will inform you about the schedule and what to expect during these visits.
Step 5
End of study
At the end of the study, all collected data will be analyzed to determine the outcomes. You will be informed about the results and any relevant findings related to your participation. Your contribution is valuable in advancing medical knowledge and treatment options for hospital-acquired bacterial pneumonia.

Who can join the trial?

11 criteria

Subjects must be willing and able to provide written informed consent, or consent must be provided by legally authorized representatives.
Female subjects of childbearing potential must be willing to use a highly effective method of birth control during the study and for at least 30 days after the last dose of study medication. This includes methods like implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or having a partner who has had a vasectomy.
Male subjects with female sexual partners of childbearing potential must agree to use medically acceptable birth control for 90 days after the last dose of study medication. This includes sexual abstinence, vasectomy, or using a condom with a spermicide. Male subjects must also agree not to donate sperm for 90 days after the last dose of study treatment.
Subjects must be willing and able to comply with all study assessments and follow the protocol schedule.
Subjects must be male or female and at least 18 years old on the day of signing informed consent.
Subjects must have hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) and require treatment with intravenous (IV) antibiotic therapy. HABP occurs at least 48 hours after hospitalization or within 7 days after discharge. VABP occurs in subjects receiving mechanical ventilation for at least 48 hours.
Subjects must have at least one of the following clinical criteria at screening: new or worsening lung symptoms like cough or difficulty breathing, low oxygen levels in the blood, need for changes in ventilator support, or new or increased respiratory secretions.
Subjects must have at least one of the following signs or laboratory abnormalities at screening: fever, low body temperature, high or low white blood cell count, or a high percentage of immature white blood cells.
Subjects must have a chest X-ray or CT scan showing new or worsening lung infiltrates suggestive of bacterial pneumonia.
Subjects must have a suspected Gram-negative bacterial infection in the lower respiratory tract, confirmed by tests like a Gram stain, microbiologic culture, or other diagnostic tests.
Subjects must agree to allow any bacterial samples obtained from required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related testing and future research.

Who cannot join the trial?

10 criteria

Patients who have a known allergy or severe reaction to the study drugs or similar drugs.
Patients who are currently participating in another clinical trial.
Patients with a history of severe liver disease.
Patients with a history of severe kidney disease.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse within the past year.
Patients who have received certain antibiotics within the last 48 hours.
Patients with a known or suspected infection caused by bacteria that are not sensitive to the study drugs.
Patients with a history of seizures or epilepsy.
Patients who have a condition that, in the opinion of the study doctor, would make participation unsafe or affect the study results.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Verified
Assistance Publique Hopitaux De Paris
Paris, France
Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain

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Investigated drugs

Imipenem/Cilastatin-XNW4107
is a combination of two medications used to treat serious bacterial infections. Imipenem is an antibiotic that kills bacteria by interfering with their cell walls, while cilastatin helps prevent the breakdown of imipenem in the kidneys, allowing it to work more effectively. XNW4107 is an additional component that may enhance the effectiveness of this combination. This medication is given through an IV, which means it is administered directly into the bloodstream, usually in a hospital setting.
Imipenem/Cilastatin/Relebactam
is another combination of medications used to treat severe bacterial infections, particularly in the lungs. Imipenem and cilastatin work together as described above, with imipenem attacking the bacteria and cilastatin helping it last longer in the body. Relebactam is added to this combination to help overcome resistance in certain bacteria, making the treatment more effective against tough infections. This medication is also administered through an IV in a hospital environment.

What is already known about the treatment

Imipenem/Cilastatin-XNW4107 – This medication is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied in clinical trials to assess its effectiveness and safety for treating hospital-acquired bacterial pneumonia, including cases that require mechanical ventilation, caused by Gram-negative bacteria. The main therapeutic use of this medication is to combat severe bacterial infections in hospital settings. At the molecular level, it works by inhibiting the synthesis of bacterial cell walls, which is essential for bacterial survival, thereby killing the bacteria. It belongs to the pharmacological class of antibiotics known as carbapenems, which are used to treat serious infections caused by bacteria.

Investigated diseases

Hospital-acquired bacterial pneumonia (HABP) – Hospital-acquired bacterial pneumonia is a lung infection that occurs in patients during their stay in a hospital, typically 48 hours or more after admission. It is caused by bacteria that are often resistant to antibiotics, making it more challenging to treat. The disease progresses as bacteria invade the lung tissue, leading to inflammation and fluid accumulation in the air sacs. Symptoms may include cough, fever, chills, and difficulty breathing. If the patient is on a ventilator, it is referred to as ventilator-associated bacterial pneumonia (VABP). The condition can worsen if not managed properly, leading to further respiratory complications.