Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression

Launched by UNIVERSITY HOSPITAL, LIMOGES · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a treatment called Interferon gamma to help prevent secondary infections in patients who are experiencing sustained immune suppression while in the Intensive Care Unit (ICU). Researchers want to find out if this treatment can lower the chances of getting infections, reduce the risk of death in the ICU, and shorten the time patients spend in the ICU and hospital. They will also be checking if the treatment helps restore the immune system and if it is cost-effective. Participants will receive either Interferon gamma or a placebo (a substance that looks like the treatment but has no active medicine) for up to five times between the first and ninth day of the study.

To be eligible for the trial, participants need to be adults who have been in the ICU for at least a week and have faced multiple organ failures during their stay. They also need to show signs of immune suppression. Patients cannot have ongoing infections or certain health conditions, such as severe liver or kidney problems, and must not be pregnant or breastfeeding. During the trial, participants will be monitored daily until they leave the ICU and will have follow-up check-ins at 30, 60, and 90 days after. This study is not yet recruiting participants, but it aims to gather important information that could help improve care for patients with weakened immune systems.

Gender

ALL

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