Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Epirubicin for the Treatment of Sepsis & Septic Shock

This clinical trial is looking at a medicine called Epirubicin for adults who are very unwell with sepsis or septic shock. Sepsis is a life-threatening reaction to an infection. Patients in this study are already in intensive care (ICU) or intermediate care in hospital. The main goal is to check how safe the medicine is, especially for its effects on the body's ability to make blood cells, over 14 days. Researchers also want to see if it helps improve organ function, reduces other side effects, and impacts how well patients recover and survive after 14, 28, and 90 days. This is an early-stage study (Phase II) to gather more information about Epirubicin.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Friedrich-Schiller-Universitaet Jena, Friedrich-Schiller-Universitaet Jena

Enrolment target

Start

01 Oct 2024

Patients with sepsis or septic shock currently hospitalized at the Intensive Care Unit (ICU) or Intermediate Care (IMC) regardless where the sepsis was first diagnosed.

What is this study about?

This study is about a medicine called Epirubicin, which doctors are exploring as a possible new treatment for a very serious condition called sepsis or septic shock. Sepsis happens when your body has an extreme response to an infection, which can cause damage to your organs and be life-threatening. If you or someone you know is in hospital with sepsis or septic shock, this trial might be relevant. The patients taking part are already being cared for in either an Intensive Care Unit (ICU) or Intermediate Care (IMC) within the hospital, regardless of where their sepsis first started.

The main thing doctors want to find out in this early-stage study (called Phase II) is how safe Epirubicin is. They will be particularly checking its effect on your body's ability to make blood cells for 14 days. This is an important safety check because some medicines can affect your bone marrow where blood cells are made.

Beyond safety, the researchers will also be looking at several other important things. They want to see if the medicine helps improve how well your organs are working, if there are any other side effects, and specifically if it affects your heart. They will also track how patients recover and survive at different points: after 14 days, 28 days, and 90 days. They will also look at how quickly a marker of infection in the blood (called procalcitonin) goes down, which might show if the treatment is working well.

Key takeaways

This study is testing a new medicine (Epirubicin) for severe sepsis or septic shock.
It's for adults already in intensive care or intermediate care in hospital.
The main aim is to check the medicine's safety, especially for blood cell production.
Researchers also want to see if it helps improve organ function and survival.
This is an early-stage study to gather more information.
You would be closely monitored throughout your participation.

Who may be eligible?

To join this study, you must be at least 18 years old. There's no upper age limit, meaning adults of any age are considered.

Both men and women can take part in this research.

Importantly, participants must already be in hospital in either the Intensive Care Unit (ICU) or Intermediate Care (IMC) because of sepsis or septic shock. This is a very specific group of patients, as the study medicines are intended for those who are seriously unwell with an infection.

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.

Am I 18 years old or older?
Am I currently in the Intensive Care Unit (ICU) or Intermediate Care (IMC) in hospital?
Have I been diagnosed with sepsis or septic shock?
Am I comfortable with regular blood tests and monitoring?
Am I happy for my health to be followed up for up to 90 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the study medicine, Epirubicin, or a salt water solution (which acts as a comparison). You would receive this through a drip while you are in hospital. The main focus during your hospital stay will be on monitoring your safety, especially checking your blood cells for up to 14 days after starting treatment.

Throughout your time in the study, doctors and nurses will closely monitor your condition. This will involve regular blood tests to check your blood cell counts and markers of infection, as well as tests to check how well your organs are working and to watch for any side effects. Your heart will also be monitored. These checks are all part of your standard care in ICU or IMC, but some may be done specifically for the study.

Even after the main treatment period, doctors will continue to check on your health and recovery at 28 days and 90 days after you started the study, usually as part of your regular medical follow-up appointments. The total duration of active monitoring for the study medicines and their immediate effects usually continues while you are in hospital, with longer-term follow-up for outcomes.

Potential risks and benefits

There could be potential benefits to taking part, such as receiving a medicine that might help improve your condition, though this is not guaranteed as it's an investigational treatment. However, there are also potential risks; Epirubicin can have side effects, and the study will be carefully monitoring for them, particularly effects on blood cells (myelotoxicity) and the heart (cardiotoxicity). You will be closely monitored by medical staff throughout the study. You always 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.

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Unverified
Germany

Common questions

What is sepsis?

Sepsis is a serious and life-threatening reaction your body can have to an infection. It can cause organs to be damaged.

What is Epirubicin?

Epirubicin is a medicine being tested to see if it can help people with sepsis. It is not currently a standard treatment for sepsis.

What does 'Phase II' mean?

Phase II means this is an early study to learn more about the medicine's safety and whether it has any effect. It's not yet approved as a standard treatment.

Will I get the actual medicine or something else?

You might get Epirubicin or a clear salt water solution (like a placebo). This helps doctors compare the effects fairly.

What does 'myelotoxicity' mean?

'Myelotoxicity' refers to an effect on your bone marrow, which is where your blood cells are made. The study will closely check this to ensure your safety.