Preventing secondary infections in ICU patients with sustained immune suppression using interferon-gamma
Official title: Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression: a Randomized Trial
Run by University Hospital, Limoges · NCT06774235 · Data updated 2026-11-12
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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 326 (estimated) |
| Sponsor | University Hospital, Limoges Academic / other |
| Drugs / interventions | Chemotherapy, radiation, prednisone, immunotherapy |
| Locations | 23 sites (Angers and 22 other locations) |
| Status | Recruiting |
| Started | July 9, 2025 |
| Main results expected | October 9, 2028 |
| Study ends | October 9, 2028 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT06774235 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 17 more locations
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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 -
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 -
Lyon Civils Hospices
Lyon, France Not yet recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.