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Study on the Effectiveness and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam for Adults with Complicated Urinary Tract Infections or Acute Pyelonephritis

Verified siteRegistered 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 treatment of complicated urinary tract infections (cUTI) and acute uncomplicated pyelonephritis (AP) in adults. These are types of infections that affect the urinary system, which includes the kidneys, bladder, and the tubes that connect them. The study will compare the effectiveness and safety of two different treatment combinations: cefepime/nacubactam and aztreonam/nacubactam, against another treatment called imipenem/cilastatin. All these medications are given through an intravenous (IV) infusion, which means they are administered directly into a vein.

The purpose of the study is to evaluate how well these treatments work and how safe they are for patients with these infections. Participants in the study will receive one of the treatment combinations or a placebo, and their progress will be monitored over a period of time. The study will involve regular visits to the clinic for check-ups and assessments to see how the infection is responding to the treatment. The goal is to find out which treatment is most effective in curing the infection and preventing it from coming back.

Throughout the study, participants will be closely observed to ensure their safety and to monitor any side effects that may occur. The study aims to provide valuable information that could help improve the treatment of these types of infections in the future. By comparing the different treatment options, researchers hope to identify the best approach for managing cUTI and AP, ultimately leading to better outcomes for patients.

The research process

The trial runs in 6 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 criteria such as age, weight, and the need for intravenous antibiotics for at least 5 days.

    The study focuses on treating complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either cefepime/nacubactam, aztreonam/nacubactam, or imipenem/cilastatin.

    All medications are administered through intravenous infusion.

  3. Step 3

    Medication administration

    The treatment involves receiving the assigned medication intravenously. The specific dosage and frequency are determined by the study protocol.

    The duration of the treatment is based on the medical condition and response to the medication.

  4. Step 4

    Monitoring and assessments

    Throughout the treatment period, regular monitoring and assessments are conducted to evaluate the effectiveness and safety of the medication.

    These assessments include clinical evaluations and laboratory tests to track progress and any side effects.

  5. Step 5

    Test of cure visit

    A visit is scheduled to determine the success of the treatment, known as the Test of Cure (TOC) visit.

    Success is measured by the resolution of symptoms and the eradication of the infection.

  6. Step 6

    Follow-up period

    After the treatment, a follow-up period is conducted to ensure the infection does not return and to monitor for any delayed side effects.

    Additional visits may be scheduled to assess long-term outcomes.

Who can join the trial?

3 criteria

  • Patients must be **male or female** and **18 years or older**. This means they must be adults or at the age of legal consent.
  • Patients must **weigh 140 kg or less**. This is about 308 pounds.
  • The doctor must believe that the patient's **complicated urinary tract infection (cUTI)** or **acute uncomplicated pyelonephritis (AP)** will need treatment with **at least 5 days of intravenous (IV) antibiotics**. Intravenous means the medicine is given directly into a vein.

Who cannot join the trial?

8 criteria

  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients with a known allergy to beta-lactam antibiotics, which include penicillins and cephalosporins.
  • Patients who have a history of liver disease or liver problems.
  • Patients with kidney problems that require dialysis.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have a condition that, in the opinion of the study doctor, would make it unsafe for them to participate.
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Investigated drugs

  • Cefepime/Nacubactam

    is a combination medication used in this study to treat complicated urinary tract infections or acute uncomplicated kidney infections. Cefepime is an antibiotic that helps kill bacteria, while Nacubactam enhances the effectiveness of Cefepime by preventing bacteria from breaking it down.

  • Aztreonam/Nacubactam

    is another combination medication being tested in the trial. Aztreonam is an antibiotic that targets and kills bacteria, and Nacubactam is included to boost the antibiotic's effectiveness by protecting it from bacterial resistance mechanisms.

  • Imipenem/Cilastatin

    is a standard treatment used as a comparison in this study. Imipenem is a powerful antibiotic that fights a wide range of bacteria, and Cilastatin is added to prevent the breakdown of Imipenem in the kidneys, ensuring it remains effective in treating infections.

What is already known about the treatment

  • Cefepime/Nacubactam

    This medication is administered through intravenous infusion and is currently being studied in clinical trials for its effectiveness and safety in treating complicated urinary tract infections and acute uncomplicated pyelonephritis. It is a combination of cefepime, a cephalosporin antibiotic, and nacubactam, a beta-lactamase inhibitor, which work together to combat bacterial infections by disrupting the bacteria's cell wall synthesis. This combination is classified under antibiotics and is being evaluated for its potential to offer a new treatment option for these infections.

  • Aztreonam/Nacubactam

    Administered via intravenous infusion, this medication is under investigation in clinical trials to determine its safety in treating complicated urinary tract infections and acute uncomplicated pyelonephritis. It combines aztreonam, a monobactam antibiotic, with nacubactam, a beta-lactamase inhibitor, to effectively target and destroy bacteria by inhibiting cell wall formation. This combination falls under the category of antibiotics and is being explored as a possible new therapy for these conditions.

Investigated diseases

  • Complicated Urinary Tract Infection (cUTI)

    This condition involves infections of the urinary tract that occur in the presence of an underlying complicating factor, such as a structural or functional abnormality of the urinary tract. It can affect the bladder, kidneys, or both, and is often caused by bacteria. Symptoms may include frequent urination, pain during urination, and abdominal pain. The infection can progress to involve the kidneys, leading to more severe symptoms. It is more challenging to treat than uncomplicated urinary tract infections due to these complicating factors.

  • Acute Uncomplicated Pyelonephritis (AP)

    This is a sudden and severe kidney infection that typically results from bacteria traveling from the bladder to the kidneys. It is characterized by symptoms such as fever, chills, back or side pain, and nausea. The condition primarily affects healthy individuals without structural or functional abnormalities of the urinary tract. If not addressed, it can lead to more severe kidney involvement. The infection is usually caused by common bacteria found in the urinary tract.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515463-55-00Protocol codeOP0595-5Estimated enrolment600 patientsSponsorMeiji Seika Pharma Co. Ltd.

sourced from the EU Clinical Trials Register and site verification

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