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Testing a Drug Combination for Personalized Sepsis Treatment in Children and Adults with Severe Blood Infection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at sepsis, a serious condition that occurs when the body has an extreme response to an infection. Sepsis can affect both children and adults and may lead to organ failure and the need for life support treatments such as machines to help with breathing, medications to support blood pressure, or treatments to help the kidneys work. The study will test several different medications to see which ones might work better for different patients with sepsis. The medications being tested include hydrocortisone, anakinra, tocilizumab, human plasma protein, interferon gamma, baricitinib, heparin, dalteparin sodium, fludrocortisone acetate, and filgrastim. Some of these medications are given through a vein, some are injected under the skin, and some are taken by mouth or through a feeding tube.

The purpose of this study is to explore how well these different treatments work compared to usual care for sepsis and to provide information that can help doctors understand which treatments might be most helpful for different patients. The study will look at whether patients survive and how many days they are able to live without needing life support treatments such as breathing machines, blood pressure medications, or kidney support within 28 days after starting the study. This information will help researchers develop ideas for future studies that can confirm which treatments work best.

During the study, patients with sepsis will be assigned to receive one of the study medications or usual care. The study will follow patients for up to three years to see how they recover. Researchers will measure survival at different time points, how many days patients spend in the hospital, how long it takes for patients to walk without help again, when they can return to their normal activities, and their quality of life. The study uses a special design that allows researchers to compare different treatments at the same time and adjust the study as new information becomes available.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and initial assessment

    Your participation in the trial begins when you are diagnosed with sepsis, which is a serious condition where your body has an extreme response to an infection.

    The medical team will confirm that you meet the study requirements, including having a documented or suspected infection and specific organ function scores that indicate sepsis.

    Your baseline health status will be assessed to determine which treatment path is most appropriate for your condition.

  2. Step 2

    Treatment assignment and initiation

    You will be assigned to receive either standard care or one of several investigational treatments based on your specific condition characteristics.

    The treatment may include one or more of the following medications, depending on your assigned group:

    Hydrocortisone: administered through a vein (intravenous).

    Anakinra: administered through injection under the skin (subcutaneous).

    Tocilizumab: administered through a vein as an infusion.

    Human plasma protein: administered through a vein as an infusion.

    Baricitinib: administered either through a feeding tube or under the skin.

    Interferon gamma: specific administration details will be provided by your medical team.

    Heparin or Dalteparin: medications to prevent blood clots, administered through a vein or under the skin.

    Fludrocortisone: administered orally or through a feeding tube.

    Filgrastim: administered under the skin.

    The specific dosage, frequency, and duration of each medication will be determined by the medical team based on your individual needs and the treatment protocol assigned to you.

  3. Step 3

    Ongoing monitoring during treatment

    Throughout your treatment, the medical team will monitor your need for life-supportive therapies.

    These therapies may include respiratory support such as high flow oxygen, breathing machines (non-invasive or invasive mechanical ventilation), or advanced lung support devices.

    You may also receive cardiovascular support through medications that help maintain your blood pressure and heart function, or devices that assist your heart.

    If needed, renal support may be provided through treatments that help your kidneys filter waste from your blood.

    The medical team will continuously assess your organ function and overall health status.

  4. Step 4

    Day 28 assessment

    At 28 days after your treatment begins, a comprehensive assessment will be conducted.

    The medical team will evaluate your survival status and count the number of days you have been alive without requiring life-supportive therapies.

    This assessment includes reviewing whether you needed respiratory support, cardiovascular support, or renal support during this period.

  5. Step 5

    Day 90 follow-up

    At 90 days after your treatment begins, your survival status will be assessed.

    You will be asked to complete questionnaires about your quality of life.

    If you are an adult, you will complete the SF-36 questionnaire and the EQ-5D-5L questionnaire, which assess your physical and mental health.

    If you are a child, the Functional Status Scale and PedsQL questionnaire will be used to evaluate your functional abilities and quality of life.

    The medical team will also assess the number of days you have spent outside of the hospital.

  6. Step 6

    One-year follow-up

    At one year after your treatment begins, your survival status will be assessed.

    You will again complete quality of life questionnaires to evaluate your physical and mental health.

    The medical team will assess the number of days you have spent outside of the hospital during this year.

    Information will be collected about your ability to walk without assistance and whether you have resumed your previous social and professional activities.

  7. Step 7

    Three-year follow-up

    At three years after your treatment begins, a final long-term assessment will be conducted.

    Your survival status will be assessed.

    You will complete quality of life questionnaires for the final time.

    The medical team will assess the total number of days you have spent outside of the hospital during these three years.

    Final information will be collected about your functional recovery, including walking ability and resumption of social and professional activities.

Who can join the trial?

7 criteria

  • You can be of any gender, male or female
  • If you are a child, you must be older than 37 weeks corrected gestational age, which means the age calculated from the expected due date rather than the actual birth date
  • You must have sepsis, which is a serious condition where the body has an extreme response to an infection that can damage organs and tissues. For adults 18 years and older, this is defined using specific criteria called Sepsis-3, and for children under 18 years, this is defined using criteria called PHOENIX sepsis
  • You must have a documented or suspected infection in your body
  • If you are an adult 18 years or older, you must have a Sequential Organ Failure Assessment score of 2 or higher, which is a measurement that shows how well your organs are working
  • If you are a child under 18 years, you must have a PHOENIX sepsis score of 2 or higher, which is a measurement used to assess the severity of sepsis in children
  • You must have health insurance

Who cannot join the trial?

1 criterion

  • The study data does not provide specific exclusion criteria, which means the reasons why patients cannot participate in this trial are not listed in the available information.
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Investigated drugs

Usual care is the standard treatment that doctors normally give to patients with sepsis. This serves as the comparison treatment in the study to see if other treatments work better. Patients receiving usual care will get the regular medications and support that hospitals typically provide for sepsis, which may include antibiotics, fluids through an IV, and machines to help with breathing or blood pressure if needed.

What is already known about the treatment

  • Interferon gamma

    Interferon gamma is a laboratory-made version of a natural immune messenger protein, given as an injection under the skin. It is approved for rare conditions such as chronic granulomatous disease and is being studied in sepsis to restore the strength of a weakened immune system. It binds to interferon receptors on immune cells, especially macrophages, and switches on genes that boost their ability to find and destroy bacteria and other microbes. It is classified as an immunostimulating cytokine (immunomodulator).

  • Tocilizumab

    Tocilizumab is a biological medicine given as an infusion into a vein. It is approved for rheumatoid arthritis, severe COVID-19 and cytokine release syndrome, and in sepsis it is being tested to calm a dangerously overactive immune response. It is a monoclonal antibody that blocks the receptor for interleukin-6, a key messenger that fuels fever and widespread inflammation; blocking the receptor interrupts this inflammatory cascade. It belongs to the group of interleukin-6 receptor inhibitors.

  • Anakinra

    Anakinra is a biological anti-inflammatory medicine given as an injection under the skin. It is approved for rheumatoid arthritis and several rare inflammatory fever syndromes, and it is studied in sepsis with excessive inflammation. It is a manufactured version of a natural blocker of interleukin-1: it occupies the interleukin-1 receptor so that this powerful inflammatory messenger can no longer dock and trigger fever and tissue damage. It is classified as an interleukin-1 receptor antagonist.

  • Baricitinib

    Baricitinib is a small-molecule anti-inflammatory medicine normally taken as a tablet; in this trial in severely ill patients it can also be given through a feeding tube. It is approved for rheumatoid arthritis, atopic dermatitis, alopecia areata and severe COVID-19. Inside immune cells it blocks enzymes called Janus kinases (JAK1 and JAK2), which pass on the signals of many inflammatory messengers; blocking them turns down the whole inflammatory response. It belongs to the group of JAK inhibitors.

  • Hydrocortisone

    Hydrocortisone is the manufactured form of cortisol, the body's own stress hormone, and in this trial it is given into a vein. It is a long-established treatment for hormone deficiency and severe inflammation, and in septic shock it is used to support blood pressure and damp down inflammation. It acts through glucocorticoid receptors inside cells, changing the activity of genes so that inflammatory proteins are produced in smaller amounts and blood vessels respond better to the body's own adrenaline-like substances. It is classified as a glucocorticoid corticosteroid.

  • Fludrocortisone

    Fludrocortisone is a corticosteroid tablet, given by mouth or through a feeding tube, that is often combined with hydrocortisone in septic shock. It is a standard medicine for conditions in which the body loses too much salt and fluid, such as adrenal insufficiency. It mainly stimulates the mineralocorticoid receptor in the kidneys, causing the body to retain salt and water, which helps stabilise blood pressure in severely ill patients. It is classified as a mineralocorticoid-type corticosteroid.

Investigated diseases

Sepsis – Sepsis is a serious medical condition that occurs when the body's response to an infection becomes harmful to its own tissues and organs. It develops when chemicals released into the bloodstream to fight an infection trigger widespread inflammation throughout the body. This inflammatory response can lead to a cascade of changes that damage multiple organ systems. As sepsis progresses, it can cause blood vessels to leak, leading to poor blood flow and preventing organs from receiving adequate oxygen and nutrients. The condition may advance rapidly and affect vital organs such as the lungs, kidneys, and heart. Without proper medical care, sepsis can progress to septic shock, where blood pressure drops dangerously low and organs begin to fail.
Trial detailsLast updated 22 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521371-31-00Protocol codeAPHP240923Estimated enrolment2 000 patientsSponsorAssistance Publique Hopitaux De Paris

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