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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Geniko Nosokomeio Peiraia Tzaneio Piraeus Greece
General Hospital Of Athens Korgialenio Benakio H.R.C. Athens Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
General Oncological Hospital Of Kifissia Agioi Anargyroi Kifissia Greece
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
General Hospital Of Eleusina Thriasio Eleusina Greece
General Hospital of Nikaia-Piraeus, “Agios Panteleimon” Piraeus Greece
Thoracic General Hospital Of Athens I Sotiria Athens Greece
Sottvaanzczh Gdgouok Hckudyth Athens Greece
Luxwj Gcdhrfy Hefxuumi Oi Azbhku Athens Greece
Ujnpowguyp Grcbppe Hiqlaizp Aesixca Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Not recruiting
01.06.2023

Trial locations

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.

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 ID:
2022-502962-26-00
Protocol code:
MODIFY
Trial Phase:
Therapeutic confirmatory (Phase III)

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