AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Pharmacokinetics of Aztreonam-Avibactam in Critically Ill Patients with Sepsis Receiving ECMO Support: A Prospective PK Study

This research is about a new medicine called Aztreonam-Avibactam. Doctors are trying to understand how this medicine works inside the bodies of adults who are extremely unwell with a serious infection called sepsis. These patients are also receiving a special kind of life support known as ECMO, which helps their heart and lungs. The study, which is an early-stage human pharmacology study, will carefully watch how the medicine is absorbed, used, and cleared from the body. This information is important because it helps doctors figure out the best and safest way to give this new medicine to patients, especially those who are very sick and on ECMO. The goal is to make sure these patients get the right amount of medicine to fight their infection effectively.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Medical University Of Vienna

Enrolment target

Start

22 Mar 2026

Sepsis

What is this study about?

This study is carefully looking into a new medicine called Aztreonam-Avibactam. The main aim is to understand exactly how this medicine acts within the bodies of adults who are very poorly due to a severe infection called sepsis. Sepsis happens when your body's reaction to an infection damages its own tissues and organs, and it can be life-threatening.

Some of these very sick patients might need a special kind of life support called ECMO. ECMO stands for Extracorporeal Membrane Oxygenation, and it's a machine that temporarily takes over the work of the heart and lungs, helping the body to recover. Because a patient's body works differently when they have sepsis and are on ECMO, it's really important to know how medicines behave in these specific situations.

This early-stage study will help doctors learn how much of the medicine stays in the body, how quickly it's used, and how it's eventually removed. This detailed information, often called 'pharmacokinetics', is crucial for figuring out the safest and most effective dose of Aztreonam-Avibactam for these seriously ill patients. By understanding this, doctors can make sure patients get the best possible treatment to fight their infection.

Key takeaways

This study is about a new antibiotic for serious infections.
It focuses on very sick adults with sepsis who are on ECMO life support.
Researchers want to understand how the medicine works in the body.
The findings will help doctors give the right dose to these patients.
Participation is for adults aged 18 and over.

Who may be eligible?

This study is for adults who are at least 18 years old. Both men and women can take part.

To be considered for this study, you would need to be very unwell with a serious infection called sepsis. You would also need to be receiving a special type of life support called ECMO, which helps your heart and lungs work.

The research team will have specific medical criteria to make sure the study is safe and that they can gather the right information. They will review your medical history and current health conditions to see if you are a good fit for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a serious infection called sepsis?
Are you currently receiving ECMO life support?
Are you an adult? (This study is not for children.)

Answer every question to see your result.

What does participation involve?

Details about what taking part in this study involves aren't fully described, but generally, in studies like this, you would likely remain in the hospital as you are already very unwell with sepsis and on ECMO. The study would involve giving you the medicine, Aztreonam-Avibactam, and then taking regular blood samples. These blood samples help the doctors measure how much of the medicine is in your body and how it's working over time.

There might be other monitoring involved, which would be part of the care you are already receiving for your sepsis and ECMO support. The total duration of your participation would depend on how long you need the medicine and how long the researchers need to follow the medicine's effects in your body. All procedures would be explained in detail by the medical team.

Potential risks and benefits

This study aims to understand how a new medicine works in very sick patients, which could help guide better treatment in the future. While there isn't a direct personal benefit guaranteed, the information gained may help improve care for others with sepsis on ECMO. Potential risks from taking part would relate to the medicine itself, which your doctor can explain, and the additional blood tests. However, all medical procedures carry some risk. You would be closely monitored by a medical team. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Austria

Common questions

What is sepsis?

Sepsis is a life-threatening reaction to an infection where your body's immune system overreacts and starts to damage your own organs and tissues.

What is ECMO?

ECMO is a machine that acts like an artificial lung and heart outside your body, giving your own organs a chance to rest and heal.

What is Aztreonam-Avibactam?

It's a new antibiotic medicine that doctors hope will help fight serious bacterial infections, like those that cause sepsis.

Why do you need to study medicines in very sick patients?

Very sick patients, especially those on life support like ECMO, process medicines differently than healthier people, so doctors need to understand the best way to give these medicines safely and effectively.

Will taking part in this study change my usual medical care?

The research team will discuss how this study fits with your ongoing care. The main goal is to gather information about the medicine, not to alter your treatment for sepsis or ECMO support, unless medically necessary.