Ireland
--:--IST
Recruiting Phase 2/3

Effect of Interferon Gamma as a Treatment for Post-aggressive Immunosuppression in Intensive Care Units, a Randomized Bayesian Double-blind Controlled Trial Versus Placebo

NCT06694740 · tracked via the Priya Life Science France tracker
Phase
Phase 2/3
Started
2026-02-24
Last updated
2026-07-06

Condition(s) studied

Post-aggressive ImmunosuppressionAdult Patients Admitted to Intensive Care With Initial Severity (SOFA of the First 24 Hours Post-admission ≥ 6Adult Under Mechanical Ventilation, and Presenting an mHLA-DR Less Than 8,000AB/C

Investigational drug(s) / intervention(s)

Interferon Gamma 1-b →Placebo

Interferon Gamma 1-b: interferon gamma-1b 2 X 106 IU, injectable solution. Subcutaneous injection every 24 hours for 3 consecutive days (3 total injections)

Placebo: Patients randomized to the placebo arm will receive saline injectable solution. Subcutaneous injection every 24 hours for 3 consecutive days (3 total injections)

Study summary

The vast majority of serious clinical situations leading to intensive care (septic shock, polytrauma, acute cerebral aggression, major surgery) are characterized by significant systemic inflammation. Recently, the existence of a common immune response pattern to acute aggression has been demonstrated, and with it the existence of a phenomenon known as post-aggressive immunosuppression (PAIS).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient ≥ 18 years old * SOFA score for first 24 hours post-admission ≥ 6 * Mechanically ventilated at the time of inclusion (non-invasive ventilation (NIV) and high-flow nasal oxygen excluded) * mHLA-DR\< 8,000 AB/C measured between the 5th and 10th day after admission to the intensive care unit * Patient affiliated to a social security scheme * Written consent (relative/trusted person) Exclusion Criteria: * Patient with estimated life expectancy of less than 3 months * Patients with a predicted remaining stay in intensive care \< 72 hours * Patient with pre-existing immunosuppression: solid cancer active or in remission for \< 5 years, active hemopathy or in remission for \< 5 years, systemic disease (including in the absence of specific treatment), solid organ transplant or marrow allograft patient, patient suffering from a HIV infection * Patients with an expected prolonged duration of mechanical ventilation: comatose or vegetative patients (admission for severe stroke with Glasgow score \< 8, patient resuscitated from an arterial stroke,) patients with tracheotomy for ENT problems, patients suffering from muscular disease (e.g. myopathy), patients on long-term mechanical ventilation * Pregnant or breast-feeding women * Contraindication of Imukin (hypersensitivity to interferon gamma-1b or known hypersensitivity to related products, such as another interferon) * Patients on immunosuppressive therapy, including long-term corticosteroid therapy (\>2.5mg/d prednisone equivalent) * Patients with severe hepatic or renal insufficiency * Patient included in another interventional clinical trial * People under court protection and protected adults

Primary outcome measure(s)

  • number of days alive without mechanical ventilation — on Day 28 after drug administration
    number of days alive without mechanical ventilation on day 28 after randomization or on discharge from intensive care if this occurs before the 28th day

Trial sites (2)

FacilityCityRegionStatus
Dr de Roquetaillade Paris France Recruiting
Pr Dépret Paris 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 NCT06694740 on ClinicalTrials.gov ↗ ← All trials in France