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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier General De Bastia Bastia France

Other Sites

Site Name City Country Status
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier De Haguenau Haguenau France
Centre Hospitalier De Tourcoing Tourcoing France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier De Bourg-En-Bresse Bourg En Bresse France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier de Dieppe Dieppe France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
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Cnqgvj Hmikjafnaxv Sib Ezsrcfzybibiuflefptgckl Etampes France
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Chhwni Hyqcyynzoln Rvjbzltv Urkqwcsmxpqcx Dm Tvvjt Tours France
Cfjwjf Hnjgeegurjp Eo Uqakdorbposkf Dj Lywfcnd Limoges France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.01.2026

Trial locations

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.

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 ID:
2025-521371-31-00
Protocol code:
APHP240923
Trial Phase:
Therapeutic exploratory (Phase II)

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