Study on Emapalumab for Patients with Sepsis Linked to Interferon-Gamma

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What is this study about?

This clinical trial is focused on studying a condition known as sepsis, which is a serious illness caused by the body’s response to an infection. The study is investigating a treatment using a medication called emapalumab. Emapalumab is a type of medicine known as a monoclonal antibody, which works by blocking a substance in the body called interferon-gamma (IFNγ). This trial is specifically looking at a form of sepsis driven by the IFNγ endotype, which is a particular pattern of the disease that affects a small percentage of patients.

The purpose of the study is to see if emapalumab can improve the health outcomes of patients with this specific type of sepsis. Participants in the study will receive emapalumab through an intravenous infusion, which means the medicine is given directly into a vein. The study will also use a placebo for comparison. The treatment period will last up to 28 days, during which the effects of the medication will be closely monitored. The study aims to find the best dosing regimen of emapalumab for managing this type of sepsis.

In addition to emapalumab, the study will use sodium chloride injection, which is a common solution used in medical treatments. The trial will help determine if emapalumab can reduce the severity of sepsis symptoms and improve patient outcomes. The findings from this study could lead to better treatment options for patients with sepsis driven by the IFNγ endotype.

1 joining the trial

Upon joining the trial, you will be required to provide written informed consent. This means you agree to participate after understanding the details of the study.

You must be an adult, 18 years or older, and have a diagnosis of certain infections such as community-acquired pneumonia or sepsis, as defined by specific medical criteria.

2 initial assessment

A blood test will be conducted to confirm the presence of interferon-gamma and CXCL9 at specific levels. These are substances in the blood that help determine if you have a particular type of sepsis.

Your medical history and current health status will be reviewed to ensure you meet all the criteria for participation.

3 treatment phase

You will receive the study medication, emapalumab, through an intravenous infusion. This means the medication will be administered directly into your vein.

The dosage and frequency of the medication will be determined by the study team based on your specific needs and response to treatment.

4 monitoring and follow-up

Throughout the trial, your health will be closely monitored. This includes regular assessments of your SOFA score, which is a measure used to track your condition.

The primary goal is to observe a decrease in your SOFA score by the end of the treatment period, which indicates an improvement in your condition.

5 end of treatment

The end of treatment is defined individually for each participant. For those requiring dosing by day 27, the evaluation will occur on day 28.

Your participation in the trial will conclude after the final assessments are completed, and you will be informed of the results.

Who Can Join the Study?

Provide written informed consent, which means you agree to participate in the study after being informed about it.
Be an adult, which means you are 18 years or older, and can be of any gender.
Have a diagnosis of certain infections, such as community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), intra-abdominal infection (IAI), acute pyelonephritis (AP), primary bloodstream infection (BSI), or viral respiratory infections.
Have sepsis as defined by the Sepsis-3 definitions. This means you have a new infection that causes an increase in your SOFA score by at least 2 points. The SOFA score is a way doctors measure how well your organs are working.
Have serological documentation of IDS, which means your blood tests show certain levels of IFNγ and CXCL9, measured in a central study lab.
Be willing to use effective contraceptive methods from the start of the study drug to 6 months after the last dose, if you are of reproductive age.
Do not have sepsis-induced immunoparalysis (SII), which means your blood tests show a certain number of HLA-DR receptors on specific immune cells, measured in a central lab.

Who Cannot Join the Study?

Patients who do not have sepsis. Sepsis is a serious condition where the body has an extreme response to an infection.
Patients who do not have the IDS endotype. IDS stands for IFNγ-Drive Sepsis, which is a specific type of sepsis.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not considered part of a vulnerable population.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Kat Attica General Hospital	Kifissia	Greece

Other Sites

Site Name	City	Country
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
University General Hospital Of Heraklion	Heraklion	Greece
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
General Hospital Of Eleusina Thriasio	Eleusina	Greece
424 Military General Training Hospital	Thessaloniki	Greece
General Hospital Of Thessloniki G Gennimatas	Thessaloniki	Greece
Asklepieion Voulas General Hospital	Voula	Greece
Hippokration Hospital	Athens	Greece
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
University General Hospital Of Ioannina	Ioannina	Greece
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Alexandra Hospital	Athens	Greece
General University Hospital Of Patras	Patras	Greece
General Hospital Of Athens Korgialenio Benakio H.R.C.	Athens	Greece
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
General Oncological Hospital Of Kifissia Agioi Anargyroi	Kifissia	Greece
Slxldfypftbm Gjfryqk Hnjlcwvw	Athens	Greece
Gybxxry Hpwuchwm Ov Tolmwstiypoo O Acciq Dpfbjlviz	Thessaloniki	Greece
Tnfyexvunq Cqnspe Hsjqfyki	Thessaloniki	Greece
Loqtt Gqtmtot Hhozgejq Ob Aaaesc	Athens	Greece
Utdtbszwxo Gpvrdya Hwknummk Acbtwsn	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	01.09.2024

Trial locations

Investigated drugs:

Emapalumab is a type of medication known as a monoclonal antibody. It works by blocking a substance in the body called interferon-gamma (IFNγ). In this clinical trial, emapalumab is being tested to see if it can help patients with a specific type of sepsis, which is a serious infection that can lead to organ failure. This type of sepsis is driven by high levels of IFNγ, and emapalumab aims to improve the health outcomes of these patients by reducing the harmful effects of IFNγ. The trial is also trying to find the best way to use emapalumab for treating this condition.

Investigated diseases:

Sepsis

Sepsis – Sepsis is a severe and potentially life-threatening condition that arises when the body’s response to infection causes injury to its own tissues and organs. It begins with an infection that can originate in any part of the body, such as the lungs, urinary tract, skin, or gastrointestinal tract. As the infection progresses, the immune system releases chemicals into the bloodstream to fight the infection, which can trigger widespread inflammation. This inflammation can lead to a cascade of changes that damage multiple organ systems, causing them to fail. The progression of sepsis can be rapid, and it may lead to septic shock, characterized by a significant drop in blood pressure that can result in severe organ dysfunction. Early recognition and management are crucial to prevent further complications.

Trial ID:

2024-515255-38-00

Protocol code:

EMBRACE

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Emapalumab for Patients with Sepsis Linked to Interferon-Gamma

What is this study about?

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