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 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT04793568
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (18yr to 85yr).
* Hospitalized in intensive care unit for less than 48 hours.
* Receiving invasive mechanical ventilation at the time of inclusion.
* One or more acute organ failure at the time of inclusion among: neurological (Glasgow coma scale \<13 before sedation), hemodynamic (norepinephrine, epinephrine, or any other vasopressor at a dose of ≥ 0.1 μg per kilogram of body weight per minute or ≥0.5 mg per hour for at least 6 hours), respiratory (PaO2 / FiO2\< 200) and/or renal (creatininemia \> 2 fold higher than the basal value and/or oliguria \< 0.5 mL/kg/hour for at less 12 hours).
* Informed consent from a legal representative, or emergency procedure (when possible according to national regulation, see below). As is not possible to obtain the patient consent prior the inclusion (comatose patients), patient consent for the study continuation will be obtained as soon as deemed possible.
* Person insured under a health insurance scheme.
Exclusion Criteria:
* Pregnant women (serum or urine test), breastfeeding women
* Patient under legal protection (incl. under guardianship or trusteeship)
* Hypersensitivity to the active substance (interferon gamma-1b) or known hypersensitivity to related products, such as another interferon, or to any of the following excipients: Mannitol, Disodium succinate hexahydrate, Succinic acid, Polysorbate 20
* Severe hepatic insufficiency ( Child Pugh score B or C)
* Liver cytolysis with hepatic enzymes (AST and/or ALT) \> 5N
* Severe chronic renal insufficiency (MDRD Creatinine Clearance \< 10 ml/min/1.73m2)
* Immunosuppression (hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, known infection Human immunodeficiency virus, concomitant use of any anti-graft rejection drug).
* Coma after resuscitated cardiac arrest
* Cervical spinal cord injury
* Participation to a drug interventional study within 1 month prior to the inclusion
* Hospital-acquired pneumonia before inclusion in the study during the current hospitalization.
* Sustained hyperlactatemia \> 5 mmol/L.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04793568
Study Brief:
Protocol Section:
NCT04793568