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Study on Avibactam and Drug Combination for Treating Severe Infections in Patients

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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 severe infections, which are serious conditions that can occur when the body's response to an infection causes injury to its own tissues and organs. The trial will explore the use of various medications, including Avibactam, Colistimethate Sodium, Vancomycin, Teicoplanin, Piperacillin, Ceftazidime, Vaborbactam, Imipenem, Relebactam, Meropenem, Ceftriaxone, Linezolid, Micafungin, Anidulafungin, Ceftolozane, Tazobactam, and Cefuroxime. These medications are administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to reduce the number of days patients are treated with broad-spectrum antibiotics, which are powerful medications used to treat a wide range of infections. The trial will compare the effectiveness of a new strategy called the MODIFY strategy, which uses procalcitonin guidance and molecular-guided diagnosis, against the standard care currently provided. Procalcitonin is a substance produced by the body in response to bacterial infections, and its levels can help guide treatment decisions.

Participants in the study will receive either the MODIFY strategy or the standard care for up to 10 days. The study will monitor various outcomes, such as the time it takes to change antibiotics, the time to achieve a sterile blood culture, and the overall length of hospital stay. The trial will also assess the impact on mortality rates and the incidence of certain infections. The goal is to find a more effective way to treat severe infections while minimizing the use of broad-spectrum antibiotics.

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 trial

    Upon joining the trial, you will provide written informed consent. If you are unable to consent due to the effects of sepsis, a legal representative may provide consent on your behalf.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying the presence of severe infections such as community-acquired pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, acute pyelonephritis, or primary bacteremia.

    A positive blood culture is required for participation.

  3. Step 3

    Treatment assignment

    You will be randomly assigned to receive either the MODIFY strategy or the standard care treatment. The MODIFY strategy aims to reduce the number of days treated with broad-spectrum antibiotics.

  4. Step 4

    Medication administration

    Medications will be administered through intravenous infusion or intravenous injection. The specific medication, dosage, and frequency will depend on the treatment group you are assigned to.

    Possible medications include avibactam, colistimethate sodium, vancomycin, teicoplanin, piperacillin, ceftazidime, vaborbactam, imipenem, ceftriaxone, linezolid, micafungin, relebactam, meropenem, anidulafungin, ceftolozane, tazobactam, and cefuroxime.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. This includes tracking the number of days under antibiotic treatment, time to first change of antibiotics, and time to the first sterile blood culture.

    Additional monitoring includes a decrease in the SOFA score by day 7, and assessments of 28-day and 90-day mortality rates.

  6. Step 6

    Completion of trial

    The trial is estimated to end by March 1, 2025. Upon completion, your participation in the study will conclude, and any further treatment will be determined by your healthcare provider.

Who can join the trial?

8 criteria

  • Must be either male or female.
  • If you are a woman who can have children, you must agree to avoid getting pregnant during the study and inform the study team if you become pregnant.
  • Must be 18 years or older.
  • Must have sepsis, which is a serious infection. This is defined by a specific score called the SOFA score that measures how well your organs are working. The score must increase by 2 points or more from when you were admitted to the hospital.
  • Must have one of the following infections: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), acute pyelonephritis (AP) (a kidney infection), or primary bacteremia (BSI) (bacteria in the blood).
  • Must have a positive blood culture, which means bacteria were found in your blood.
  • Must provide written informed consent, which means you agree to participate in the study. If you are unable to consent due to your condition, a legal representative can do this for you.
  • If you have participated in another study, you must have completed it more than 30 days ago to join this study.

Who cannot join the trial?

1 criterion

  • Patients with severe infections cannot participate. A severe infection is a serious illness caused by harmful germs that can make you very sick.
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Investigated drugs

  • Procalcitonin-Guided Therapy

    is a treatment approach that uses the levels of a substance called procalcitonin in your blood to help guide decisions about antibiotic use. Procalcitonin is a marker that can indicate the presence of a bacterial infection. In this trial, doctors use procalcitonin levels to decide when to start or stop antibiotics, aiming to reduce unnecessary antibiotic use and help treat severe infections more effectively.

  • Molecular-Guided Diagnosis

    is a method that uses advanced technology to identify the specific bacteria or viruses causing an infection. This approach helps doctors choose the most effective treatment by targeting the exact cause of the infection. In the trial, this method is used to ensure that patients receive the right antibiotics, reducing the use of broad-spectrum antibiotics and improving treatment outcomes for severe infections.

What is already known about the treatment

Procalcitonin-Guided Therapy – This medication is administered through a blood test that measures the level of procalcitonin, a substance produced by the body in response to bacterial infections. It is currently being studied in clinical trials, such as the MODIFY trial, to determine its effectiveness in reducing the duration of antibiotic treatment for severe infections. The main therapeutic indication is to guide the use of antibiotics, helping doctors decide when to start or stop antibiotic therapy. At the molecular level, procalcitonin levels rise in response to bacterial infections, providing a signal for the presence of such infections. It is classified as a diagnostic tool rather than a traditional medication, as it helps in making treatment decisions rather than directly treating the infection.

Investigated diseases

Severe infections – Severe infections are caused by pathogenic microorganisms such as bacteria, viruses, fungi, or parasites that invade the body and multiply, leading to significant illness. These infections can affect various parts of the body, including the lungs, bloodstream, or other organs, and can result in systemic inflammation. The progression of severe infections often involves an initial phase of localized symptoms, which can rapidly escalate to systemic involvement if not controlled. As the infection spreads, it can lead to symptoms such as high fever, chills, fatigue, and organ dysfunction. The body's immune response to the infection can sometimes cause additional damage, leading to complications. The severity and progression depend on the type of pathogen, the site of infection, and the individual's immune response.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502962-26-00Protocol codeMODIFYEstimated enrolment190 patientsSponsorHellenic Institute For The Study Of Sepsis

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).