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Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Resistant Bacterial Infections

Fast replyRegistered drugNo placebo
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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 effectiveness and safety of two treatment combinations for certain serious infections. The diseases being studied include complicated urinary tract infection, acute uncomplicated pyelonephritis (a type of kidney infection), hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated intra-abdominal infection. These infections are caused by a group of bacteria known as carbapenem-resistant Enterobacterales, which are difficult to treat due to their resistance to many antibiotics.

The trial will compare the treatment combinations of cefepime/nacubactam and aztreonam/nacubactam against the best available therapy currently used for these infections. Cefepime and aztreonam are antibiotics, while nacubactam is a substance that helps these antibiotics work better against resistant bacteria. The study will involve administering these treatments through an intravenous infusion, which means the medication is given directly into a vein.

Participants in the study will receive one of the treatment combinations or the best available therapy for up to 14 days. The goal is to determine which treatment is most effective in achieving overall treatment success across all the infection types mentioned. The study will also monitor the safety of the treatments to ensure they are safe for use in patients. This trial aims to provide valuable information that could lead to better treatment options for these challenging infections.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, weight, and infection type.

    The study focuses on infections caused by carbapenem-resistant Enterobacterales, including complicated urinary tract infections, acute uncomplicated pyelonephritis, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated intra-abdominal infections.

  2. Step 2

    Treatment initiation

    Treatment begins with the administration of medications through intravenous infusion. The medications used include cefepime/nacubactam and aztreonam/nacubactam.

    The goal is to assess the effectiveness and safety of these medications in treating the specified infections.

  3. Step 3

    Treatment period

    During the treatment period, the patient remains hospitalized to receive the intravenous medications.

    The duration of the treatment is determined by the specific infection type and the patient's response to the medication.

  4. Step 4

    Monitoring and assessment

    Throughout the study, the patient's health and response to treatment are closely monitored.

    The primary measure of success is the overall treatment success across all infection types, evaluated at the end of the treatment course.

  5. Step 5

    Completion of study

    Upon completion of the treatment period, the patient's outcomes are assessed to determine the success of the treatment.

    The study aims to provide insights into the efficacy and safety of the medications for the specified infections.

Who can join the trial?

7 criteria

  • Must be a male or female who is at least 18 years old or older, depending on the legal age of consent in your area.
  • Must weigh 140 kg or less.
  • Must be able to stay in the hospital during the treatment period.
  • If you have a known infection caused by **CRE** (a type of bacteria resistant to certain antibiotics), you must meet one of the following:
    • Have a confirmed CRE infection based on lab tests within 72 hours (or 96 hours for certain infections) before starting the study medication, and have received no more than 24 hours of an antibiotic that the CRE is known to be sensitive to within that time frame.
    • Have a confirmed CRE infection based on lab tests within 72 hours (or 96 hours for certain infections) before starting the study medication, and show signs that previous treatment with an antibiotic the CRE is sensitive to has not worked after at least 48 hours.
    • If you have a suspected CRE infection, you must meet one of the following:
      • Have a suspected CRE infection based on tests or previous records within 90 days before starting the study medication, and have received no more than 24 hours of initial antibiotic treatment for certain bacteria within 72 hours (or 96 hours for certain infections) before starting the study medication.
      • Have a suspected CRE infection based on tests or previous records within 90 days before starting the study medication, and show signs that previous initial antibiotic treatment for certain bacteria has not worked after at least 48 hours.

Who cannot join the trial?

10 criteria

  • Patients who have allergies or severe reactions to the study medications, which include cefepime, nacubactam, or aztreonam, cannot participate.
  • Individuals with a history of severe allergic reactions to similar antibiotics, such as penicillins or cephalosporins, are excluded.
  • Patients with kidney problems that require dialysis are not eligible.
  • Those with liver disease that affects liver function significantly cannot join the study.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Patients who are currently participating in another clinical trial are excluded.
  • Individuals with a history of drug or alcohol abuse that might interfere with the study are not eligible.
  • Patients with certain types of infections that are not the focus of the study, such as viral infections, are excluded.
  • Individuals who have received certain antibiotics within a specific time frame before the study starts cannot participate.
  • Patients with a weakened immune system, such as those with HIV/AIDS or undergoing chemotherapy, are not eligible.
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Investigated drugs

  • Cefepime/Nacubactam

    is a combination medication used in this study to treat various serious infections. Cefepime is an antibiotic that helps kill bacteria, while Nacubactam enhances the effectiveness of Cefepime by inhibiting certain enzymes that bacteria use to resist antibiotics. This combination is administered through an intravenous infusion to treat complicated urinary tract infections, acute uncomplicated kidney infections, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated intra-abdominal infections caused by resistant bacteria.

  • Aztreonam/Nacubactam

    is another combination medication being tested in the trial. Aztreonam is an antibiotic that targets and kills bacteria, and Nacubactam works alongside it to block bacterial resistance mechanisms. This combination is also given through an intravenous infusion and is aimed at treating the same types of serious infections as the Cefepime/Nacubactam combination, particularly those caused by bacteria that are resistant to other antibiotics.

What is already known about the treatment

  • Cefepime/Nacubactam

    This medication is administered through intravenous infusion and is currently being studied in clinical trials. It is being evaluated for its effectiveness and safety in treating complicated urinary tract infections, acute uncomplicated pyelonephritis, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, and complicated intra-abdominal infections caused by carbapenem-resistant Enterobacterales. The combination works by inhibiting bacterial cell wall synthesis, with cefepime acting as a broad-spectrum antibiotic and nacubactam enhancing its activity by inhibiting beta-lactamase enzymes. It is classified as a beta-lactam/beta-lactamase inhibitor combination.

  • Aztreonam/Nacubactam

    This medication is also administered via intravenous infusion and is under investigation in clinical trials. It is intended for the treatment of the same infections as cefepime/nacubactam, particularly those caused by carbapenem-resistant Enterobacterales. Aztreonam functions as a monobactam antibiotic, targeting bacterial cell wall synthesis, while nacubactam boosts its efficacy by blocking beta-lactamase enzymes. This combination is categorized as a monobactam/beta-lactamase inhibitor.

Investigated diseases

  • Complicated Urinary Tract Infection (cUTI)

    This condition involves infections of the urinary tract that are associated with structural or functional abnormalities, making them more difficult to treat. It can affect the bladder, kidneys, or both, and may lead to more severe symptoms than uncomplicated infections. Patients may experience frequent urination, pain during urination, and abdominal pain. The infection can progress to the kidneys, causing more severe symptoms like fever and back pain.

  • Acute Uncomplicated Pyelonephritis (AP)

    This is a sudden and severe kidney infection that typically occurs in healthy individuals with no structural or functional urinary tract abnormalities. It often starts as a bladder infection and progresses to the kidneys, causing symptoms such as high fever, chills, and flank pain. The condition can lead to nausea and vomiting, and requires prompt medical attention to prevent complications.

  • Hospital-Acquired Bacterial Pneumonia (HABP)

    This type of pneumonia is acquired during a hospital stay, typically 48 hours or more after admission. It is caused by bacteria and can lead to symptoms such as cough, fever, and difficulty breathing. The condition can progress rapidly, especially in patients with weakened immune systems or underlying health issues.

  • Ventilator-Associated Bacterial Pneumonia (VABP)

    This pneumonia occurs in patients who are on mechanical ventilation for at least 48 hours. It is caused by bacteria that enter the lungs through the ventilator tube, leading to symptoms like fever, increased respiratory secretions, and changes in lung function. The condition can complicate the recovery of critically ill patients.

  • Complicated Intra-Abdominal Infection (cIAI)

    This infection occurs within the abdominal cavity and involves multiple organs, often following surgery or trauma. It can lead to symptoms such as severe abdominal pain, fever, and nausea. The infection can spread to other parts of the body, making it more challenging to manage.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515180-56-00Protocol codeOP0595-6Estimated enrolment150 patientsSponsorMeiji Seika Pharma Co. Ltd.

sourced from the EU Clinical Trials Register and site verification

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