Ireland
--:--IST
Recruiting Phase 3

Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression

NCT06774235 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2025-07-09
Last updated
2025-11-20

Condition(s) studied

Sustained Immunosuppression

Investigational drug(s) / intervention(s)

Interferon Gamma 1-b →Placebo

Interferon Gamma 1-b: injection of interferon gamma 1-b

Placebo: Injection of placebo in the same condition of experimental traitment

Study summary

The goal of this clinical trial is to demonstrate the benefit of a standardized immunotherapy (Interferon gamma) on the incidence of secondary infections. . It will also learn about the safety of Interferon-gamma. The main questions it aims to answer are:

Does Interferon-gamma:

* reduces the Incidence of secondary infection episodes at three months
* reduces the ICU mortality and at Day 90
* reduces the ICU and hospital length of stay
* induces Biological immune restoration at Day 10
* has cost-consequence and cost-effectiveness

Researchers will compare Interferon-gamma to a placebo (a look-alike substance that contains no drug) to see if Interferon-gamma works to treat sustained immunosuppression .

Participants will:

* Take Interferon-Gamma or a placebo for a maximum of 5 times between day 1 and day 9
* be monitored evety day until their ICU discharge and at day 30, 60 and 90

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of secondary infection episodes — Day 90
    Number of episodes divided by the follow-up length, in days, validated by an independent adjudication committee based on the current definitions.

Trial sites (23)

FacilityCityRegionStatus
Angers university hospial Angers France Recruiting
Argenteuil hospital Argenteuil France Recruiting
Franche-comté north Hospital Belfort France Recruiting
Brive Hospital Brive-la-Gaillarde France Recruiting
Chalon sur saone Hospital Chalon-sur-Saône France Recruiting
Dijon University Hospital Dijon France Recruiting
APHP - Raymond Poincaré Garches France Recruiting
Versailles Hospital Le Chesnay France Recruiting
Le mans Hospital Le Mans France Recruiting
CH de Lens Lens France Recruiting
Limoges University Hospital Limoges France Recruiting
Lyon Civils Hospices Lyon France Not Yet Recruiting
APHM Marseille France Recruiting
Melun Hospital Melun France Recruiting
Nancy University Hospital Nancy France Recruiting
Nantes University Hospital Nantes France Recruiting
Orléans Hospital Orléans France Recruiting
APHP - Laroiboisière Paris France Recruiting
Aphp - Hegp Paris France Recruiting
APHP - Cochin Paris France Recruiting
Rennes University Hospital Rennes France Recruiting
Strasbourg University Hospital Strasbourg France Recruiting
Tours University Hospital Tours France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06774235 on ClinicalTrials.gov ↗ ← All trials in France