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Experimental drug aims to shield ICU patients from deadly infections

NCT ID NCT06774235

Disease control Sponsor: University Hospital, Limoges 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 3 trial tests whether a drug called interferon gamma can prevent secondary infections in ICU patients whose immune systems are suppressed. About 326 adults who have been in the ICU for at least a week and show signs of immune weakness will receive either the drug or a placebo. The goal is to see if the drug reduces infection rates and improves recovery.

What this could mean

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

Active substance
Interferon gamma 1-b
What this could lead to
If it works, this could reduce dangerous secondary infections in ICU patients with weakened immune systems, potentially saving lives and shortening hospital stays.
What could go wrong
This is a phase 3 trial, but the treatment is given for only a short time and may not work for everyone. There is also a risk of side effects from the drug.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 326 people

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

Started

Jul 2025

Expected to finish

Oct 2028

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

18 years 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.

Inclusion Criteria: * Adult patient hospitalized in the ICU for at least 1 week * Expected length of stay in the ICU greater than 10 days at screening * At least 1 episode of multiple organ failure, defined as a SOFA ≥ 6 (excluding the respiratory component when related to a neurological failure), during the first 1 week of ICU hospitalization * Immunosuppression defined as an mHLA-DR \< 8000 Ab/c and a lymphopenia \< 1000/mm3 within a 96 hours time window * Patient or the legal representative giving consent must be able to understand the trial in its entirety * Patient affiliated to the social security system * For female participants of childbearing potential, agreement to use dual methods of contraception until Day 90 * For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 90. Exclusion Criteria: * Uncontrolled secondary infections ongoing at the time of screening * Participation in another research clinical trial within 30 days * Chemotherapy / radiation therapy within the last 6 weeks * Apache II ≥ 30 at screening * History of autoimmune disease * Organ or bone marrow transplant * History of hematologic malignancy * History of hepatitis C * HIV stage C within the last 12 months * Patients under legal protection * History of or ongoing tuberculosis * Chronic hepatitis B * Patients receiving immunosuppressive medications including patient receiving a steroid dose greater than 1mg/kg/day of prednisone equivalent for more than 1 week and patient that have been on corticosteroid for more than 3 months * Patient with thrombocytopenia below 50,000/mm3 * Patient with traumatic brain and spinal injury * Pregnancy or breast feeding * Subjects with a history hypersensitivity to interferon gamma or excipient (Mannitol, Sodium succinate dibasic hexahydrate, Succinic acid, polysorbate 20), known latex hypersensitivity or other interferon * Hepatic cytolysis with AST/ALT \> 5 times ULN (local laboratory) * Suspected acute pancreatitis with lipase or amylase \> 3 times ULN (local laboratory) * Severe chronic renal failure (eGFR\<10 ml/min/1.73m2 CKP-EPI method) * Acute ECG abnormality such as myocardial infarction or any acute life-threatening ECG abnormalities (e.g: ventricular fibrillation, ventricular tachycardia…) * Mental state rendering the person giving consent incapable of understanding the trial * Patient deprived of liberty by judicial or administrative decision * Patient being the investigator, or any member of the team or relative of the investigator directly involved in the trial, including assistant doctors, pharmacists, nurses, trial coordinators

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Conditions

The condition(s) this trial relates to.

coinfection

As listed by the trial registrant

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

Sustained immunosuppression

How to take part

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

  1. The places running it

    23 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

  • APHM

    RECRUITING

    Marseille, 13915, France

  • APHP - Cochin

    RECRUITING

    Paris, 75015, France

  • APHP - Laroiboisière

    RECRUITING

    Paris, 75010, France

  • APHP - Raymond Poincaré

    RECRUITING

    Garches, 92380, France

  • Angers university hospial

    RECRUITING

    Angers, 49100, France

  • Aphp - Hegp

    RECRUITING

    Paris, 75014, France

  • Argenteuil hospital

    RECRUITING

    Argenteuil, 95107, France

  • Brive Hospital

    RECRUITING

    Brive-la-Gaillarde, 19100, France

  • CH de Lens

    RECRUITING

    Lens, 62300, France

  • Chalon sur saone Hospital

    RECRUITING

    Chalon-sur-Saône, 71100, France

  • Dijon University Hospital

    RECRUITING

    Dijon, 21000, France

  • Franche-comté north Hospital

    RECRUITING

    Belfort, 90015, France

  • Le mans Hospital

    RECRUITING

    Le Mans, 72000, France

  • Limoges University Hospital

    RECRUITING

    Limoges, 87042, France

  • Lyon Civils Hospices

    NOT_YET_RECRUITING

    Lyon, 69002, France

  • Melun Hospital

    RECRUITING

    Melun, 77000, France

  • Nancy University Hospital

    RECRUITING

    Nancy, 54035, France

  • Nantes University Hospital

    RECRUITING

    Nantes, 44000, France

  • Orléans Hospital

    RECRUITING

    Orléans, 45100, France

  • Rennes University Hospital

    RECRUITING

    Rennes, 35000, France

  • Strasbourg University Hospital

    RECRUITING

    Strasbourg, 67091, France

  • Tours University Hospital

    RECRUITING

    Tours, 37000, France

  • Versailles Hospital

    RECRUITING

    Le Chesnay, 78157, France