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Prevention study for Sustained Immunosuppression
Official title Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression
ClinicalTrials.gov ID: NCT06774235
What this study is testing
What is Interferon Gamma 1-b?
Interferon Gamma 1-b is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for sustained immunosuppression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to demonstrate the benefit of a standardized immunotherapy (Interferon gamma) on the incidence of secondary infections. .
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- Patient with thrombocytopenia below 50,000/mm3
- Patient with traumatic brain and spinal injury
- Pregnancy or breast feeding
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Argenteuil, France
- Belfort, France
- Brive-la-Gaillarde, France
- Chalon-sur-Saône, France
- Dijon, France
- Garches, France
- Le Chesnay, France
- Le Mans, France
- Lens, France
- Limoges, France
- Lyon, France
- Marseille, France
- Melun, France
- Nancy, France
- Nantes, France
- Orléans, France
- Paris, France
- Rennes, France
- Strasbourg, France
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Argenteuil, France; Belfort, France; Brive-la-Gaillarde, France; Chalon-sur-Saône, France; Dijon, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.