Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT06774235
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06774235
Study Brief:
Protocol Section:
NCT06774235