Prevention of secondary infections by interferon gamma in ICU-acquired sustained immune-suppression: a randomized trial

Phase 3

Recruiting

• Conditions: Sustained immunosuppression

• Registration Number: 2024-516780-93-00
• Lead Sponsor: Centre Hospitalier Et Universitaire De Limoges

Brief Summary

To demonstrate the benefit of a standardized immunotherapy with IFN-γ versus placebo on the incidence of secondary infections at three months (Day 90) in ICU patients with documented sustained immunosuppression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-14
• Study Start: 2025-07-09
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-04
• Last Update Posted: 2025-09-11
• Primary Completion: 2028-10-09
• Study Completion: 2028-10-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of secondary infection episodes at three months (Day 90) validated by an independent adjudication committee based on the current standardized definitions (CDC surveillance definitions, January 2024)		Incidence of secondary infection episodes at three months (Day 90) validated by an independent adjudication committee based on the current standardized definitions (CDC surveillance definitions, January 2024)

Secondary Outcome Measures

Name	Time	Method
All-cause ICU mortality and at Day 90		All-cause ICU mortality and at Day 90
Length of stay in the ICU and in the hospital at Day 90		Length of stay in the ICU and in the hospital at Day 90
Antibiotic and antifungal consumption at Day 90		Antibiotic and antifungal consumption at Day 90
Percentage of biological immune restoration (defined as an HLA-DR > 13 500 Ab/c [Antibodies bound per cell] and an absolute lymphocyte count > 1200 mm3) at Day 10		Percentage of biological immune restoration (defined as an HLA-DR > 13 500 Ab/c [Antibodies bound per cell] and an absolute lymphocyte count > 1200 mm3) at Day 10
Healthcare costs at Day 90, cost per secondary infection avoided and cost per additional survivor, isolation requirement and antibiotic resistance		Healthcare costs at Day 90, cost per secondary infection avoided and cost per additional survivor, isolation requirement and antibiotic resistance
Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) at D90		Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) at D90

Trial Locations

Locations (23)

Angers university hospial; 🇫🇷 Angers, France

Argenteuil hospital; 🇫🇷 Argenteuil, France

Franche-comté north Hospital; 🇫🇷 Belfort, France

Brive Hospital; 🇫🇷 Brive-la-Gaillarde, France

Chalon sur saone Hospital; 🇫🇷 Chalon-sur-Saône, France

Dijon University Hospital; 🇫🇷 Dijon, France

APHP - Raymond Poincaré; 🇫🇷 Garches, France

Versailles Hospital; 🇫🇷 Le Chesnay, France

Le mans Hospital; 🇫🇷 Le Mans, France

CH de Lens; 🇫🇷 Lens, France

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