EMAPALUMAB TREATMENT FOR ANTICIPATED CLINICAL BENEFIT IN SEPSIS DRIVEN BY THE INTERFERON-GAMMA ENDOTYPE (THE EMBRACE TRIAL)
Sepsis is a life-threatening condition that occurs when the body's immune system overreacts to an infection, potentially causing vital organs like the lungs, kidneys, and heart to fail. The EMBRACE trial is looking at a new treatment called emapalumab for adults hospitalised with severe sepsis. Emapalumab works by calming down a specific inflammatory signal in the body known as interferon-gamma, which can drive dangerous organ inflammation. During the study, half of the patients will receive emapalumab through a drip, while others receive a dummy drip (saline solution) alongside their normal hospital care. Doctors will monitor patients closely using an organ health scale called the SOFA score. The main goal is to find out whether emapalumab can reduce organ damage, help patients recover, and increase survival rates over a 28-day hospital period.
At a glance
What is this study about?
Sepsis is a medical emergency that happens when the body develops a dangerous, out-of-control reaction to an infection. While the immune system normally fights off bugs, in sepsis it accidentally attacks healthy tissues and organs. This can lead to organs like the liver, kidneys, and lungs struggling to work properly, requiring intensive hospital care.
In some people with sepsis, a natural body protein called interferon-gamma becomes overactive. This causes extreme inflammation that makes organ damage worse. The EMBRACE clinical trial is investigating a medicine called emapalumab, which specifically targets and blocks this protein to help calm the immune system down.
Researchers want to find out whether adding emapalumab to standard hospital treatment can protect organs from failure and improve recovery. By comparing emapalumab against a standard salt-water dummy drip, the trial aims to see if the medicine helps patients get better faster and improves overall survival over four weeks.
Key takeaways
- Phase II clinical trial testing emapalumab for adults hospitalised with sepsis.
- Aims to protect vital organs by blocking a protein that causes runaway inflammation.
- Patients receive either the trial medicine or a dummy saline drip alongside full standard care.
- Monitors organ recovery closely using the SOFA score over up to 28 days.
- Participation is voluntary and does not change your right to standard medical treatments.
Who may be eligible?
This trial is open to adults aged 18 and older who are in hospital with sepsis. Both men and women can take part if they meet the medical criteria.
Because this study focuses on a specific type of immune reaction, doctors will look for signs that a patient's sepsis involves high levels of inflammation linked to interferon-gamma. Patients will also need to show signs that their organs need extra support.
Since sepsis is an urgent, critical illness, patients are usually identified and assessed directly by hospital intensive care or acute medical teams. If someone is too unwell to give consent themselves, a family member or legal representative may be asked on their behalf.
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.
- You are aged 18 years or older.
- You have been diagnosed with sepsis in the hospital.
- Your medical team has identified signs of organ strain needing close monitoring.
- You have the specific inflammatory profile (interferon-gamma response) being studied.
- You or a family representative are willing to take part in a hospital-based research trial.
What does participation involve?
Taking part in this study happens entirely while receiving care in hospital. Participants are placed into one of two groups by chance: one group receives emapalumab through a drip (an infusion into a vein), and the other group receives a harmless salt-water drip. Both groups continue to get full standard hospital care, such as antibiotics and fluids.
The medical team will track daily blood tests and organ function using a clinical tool called the SOFA score, which measures how well the lungs, liver, kidneys, and circulation are working. Doses of the study medicine are given as needed based on the doctor's assessment during treatment.
Patients are closely monitored for up to 28 days. Because all tests and treatments happen as part of inpatient hospital care, no separate outpatient visits are needed during this acute phase.
Potential risks and benefits
Locations (1)
- —UnverifiedGreece
Common questions
What is the difference between standard sepsis care and this trial?
All participants receive standard sepsis care, such as antibiotics and organ support. The trial simply tests whether adding emapalumab gives better organ protection than standard care alone.
How is the medicine given?
It is given as an intravenous (IV) drip directly into a vein, just like many standard hospital fluids and medicines.
Can I choose which treatment group I am in?
No. A computer assigns participants at random to either emapalumab or a salt-water dummy drip, ensuring the study results are fair and unbiased.
What is a SOFA score?
The Sequential Organ Failure Assessment (SOFA) score is a routine medical scale that doctors use to track how well six vital body systems are functioning.
What happens if a patient cannot communicate their consent?
Because sepsis causes severe confusion or unconsciousness, standard UK legal procedures allow a close family member or designated doctor to give agreement on the patient's behalf.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.