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Preventing secondary infections in ICU patients with sustained immune suppression using interferon-gamma

Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression: a Randomized Trial

Phase 3 Interventional University Hospital, Limoges · NCT06774235

This trial will test whether short courses of interferon-gamma can reduce secondary infections and improve outcomes for ICU patients with sustained immune suppression.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment326 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital, Limoges Academic / other
Drugs / interventionsChemotherapy, radiation, prednisone, immunotherapy
Locations23 sites (Angers and 22 other locations)
Trial IDNCT06774235 on ClinicalTrials.gov

What this trial studies

This is a randomized, placebo-controlled Phase 3 trial enrolling adult ICU patients with sustained immunosuppression (mHLA-DR < 8000 Ab/c and lymphopenia < 1000/mm3) who have been hospitalized in the ICU for at least one week and had episodes of multiple organ failure. Participants will receive up to five doses of interferon-gamma 1-b or matching placebo between day 1 and day 9 and will be monitored daily until ICU discharge with follow-up visits at days 30, 60, and 90. Primary outcomes include the incidence of secondary infection episodes at three months, with secondary endpoints such as ICU and day-90 mortality, ICU and hospital length of stay, biological immune restoration at day 10, and health economic analyses. The trial is led by the University Hospital of Limoges with participating French ICU sites in Angers, Argenteuil, and Belfort.

Who should consider this trial

Good fit: Adults in the ICU for at least one week with expected ICU stay >10 days, prior multiple organ failure (SOFA ≥6), and documented immunosuppression (mHLA-DR <8000 Ab/c and lymphopenia <1000/mm3) are ideal candidates.

Not a fit: Patients with uncontrolled ongoing secondary infections at screening, those without documented immune suppression, or those enrolled in other interventional research are unlikely to benefit from participation.

Why it matters

Potential benefit: If effective, interferon-gamma could reduce secondary infections, shorten ICU and hospital stays, and lower mortality in this high-risk patient group.

How similar studies have performed: Small pilot studies of interferon-gamma in sepsis-related immunosuppression have shown biological immune restoration and signals of fewer infections, but large randomized phase 3 evidence has been limited until now.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Angers and 22 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Sustained ImmunosuppressionICUImmuno-restaurationSecondary infectionsPrevention
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.