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New trial aims to match sepsis treatments to Patients' unique traits

NCT ID NCT06381661

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tests whether giving sepsis patients drugs tailored to their specific biological traits can improve survival and reduce the need for life support. It will enroll 2000 adults and children across multiple countries, using an adaptive platform to test several treatments at once. The goal is to move away from one-size-fits-all sepsis care toward more personalized medicine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tocilizumab, Baricitinib, Anakinra, Hydrocortisone
What this could lead to
If successful, this could show that matching sepsis treatments to individual patient traits improves survival and reduces time on life support.
What could go wrong
This is an early Phase 2 exploratory trial, so results may not confirm effectiveness. The complex adaptive design may also make it harder to draw clear conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

37 weeks and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Platform inclusion criteria will be: * All genders patients * Aged \>37 weeks corrected gestational age * Sepsis as per Sepsis-3 definition for adults, and as per the PHOENIX sepsis for children Briefly, all following criteria will be required: 1. Documented or suspected infection, 2. Sequential Organ Failure Assessment (SOFA) score ≥2 for adults, and PHOENIX sepsis score of ≥2 for children. * Health insurance Platform exclusion criteria: Any of the following: * Refusal to consent for participating in the study, * Pregnancy measured by beta-HCG blood levels * Breast feeding * Acute coronary disease in the past 3 months * Stroke episode in the past 3 months * Any condition for which patient's primary physician will consider inappropriate enrolling patient in the study Treatable trait inclusion criteria : * Hyperinflammation : Subphenotypes Beta, Delta, Gamma for adults; Subphenotypes PedSep-B, C, D for children * Hypoinflammation : lymphocytes count \< 1.0 × 10\^9/L * Macrophage Activation Like Syndrome : Ferritin \>4,420 ng/mL for adults, Ferritin \>500 ng/mL for children * Corticosteroids: Positive for i-RECORDS algorithm signature * Hypercoagulation (adults) : Prothrombin time (PT)/INR ≥ 1.40 AND Platelet count \< 150 000/mm3 or greater than 30% decrease in platelets in 24 hours * Hypofibrinolysis (adults): Plasminogen deficit \< 0.5 µmol/L There are also inclusion and exclusion criteria related to treatable traits and interventions.

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Conditions

The condition(s) this trial relates to.

infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHD Vendée - infectiologie

    RECRUITING

    La Roche-sur-Yon, France

  • CHD Vendée - réanimation adulte

    RECRUITING

    La Roche-sur-Yon, France

  • CHU Dijon - infectiologie

    RECRUITING

    Dijon, France

  • CHU Dijon - réanimation adulte

    RECRUITING

    Dijon, France

  • Hôpital Raymond Poincaré

    RECRUITING

    Garches, France

  • Hôpital Raymond Poincaré - infectiologie

    RECRUITING

    Garches, France

  • Hôpital Saint Antoine AP-HP - infectiologie

    RECRUITING

    Paris, France

  • Hôpital Saint Antoine AP-HP - réanimation adulte

    RECRUITING

    Paris, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.