Actively Recruiting
Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression
Led by University Hospital, Limoges · Updated on 2025-11-20
326
Participants Needed
23
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to demonstrate the benefit of a standardized immunotherapy (Interferon gamma) on the incidence of secondary infections. . It will also learn about the safety of Interferon-gamma. The main questions it aims to answer are: Does Interferon-gamma: * reduces the Incidence of secondary infection episodes at three months * reduces the ICU mortality and at Day 90 * reduces the ICU and hospital length of stay * induces Biological immune restoration at Day 10 * has cost-consequence and cost-effectiveness Researchers will compare Interferon-gamma to a placebo (a look-alike substance that contains no drug) to see if Interferon-gamma works to treat sustained immunosuppression . Participants will: * Take Interferon-Gamma or a placebo for a maximum of 5 times between day 1 and day 9 * be monitored evety day until their ICU discharge and at day 30, 60 and 90
CONDITIONS
Official Title
Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 63 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.
You will not qualify if you...
- 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 63 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 tachycardia026)
- 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
AI-Screening
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Trial Site Locations
Total: 23 locations
1
Angers university hospial
Angers, France, 49100
Actively Recruiting
2
Argenteuil hospital
Argenteuil, France, 95107
Actively Recruiting
3
Franche-comté north Hospital
Belfort, France, 90015
Actively Recruiting
4
Brive Hospital
Brive-la-Gaillarde, France, 19100
Actively Recruiting
5
Chalon sur saone Hospital
Chalon-sur-Saône, France, 71100
Actively Recruiting
6
Dijon University Hospital
Dijon, France, 21000
Actively Recruiting
7
APHP - Raymond Poincaré
Garches, France, 92380
Actively Recruiting
8
Versailles Hospital
Le Chesnay, France, 78157
Actively Recruiting
9
Le mans Hospital
Le Mans, France, 72000
Actively Recruiting
10
CH de Lens
Lens, France, 62300
Actively Recruiting
11
Limoges University Hospital
Limoges, France, 87042
Actively Recruiting
12
Lyon Civils Hospices
Lyon, France, 69002
Not Yet Recruiting
13
APHM
Marseille, France, 13915
Actively Recruiting
14
Melun Hospital
Melun, France, 77000
Actively Recruiting
15
Nancy University Hospital
Nancy, France, 54035
Actively Recruiting
16
Nantes University Hospital
Nantes, France, 44000
Actively Recruiting
17
Orléans Hospital
Orléans, France, 45100
Actively Recruiting
18
APHP - Laroiboisière
Paris, France, 75010
Actively Recruiting
19
Aphp - Hegp
Paris, France, 75014
Actively Recruiting
20
APHP - Cochin
Paris, France, 75015
Actively Recruiting
21
Rennes University Hospital
Rennes, France, 35000
Actively Recruiting
22
Strasbourg University Hospital
Strasbourg, France, 67091
Actively Recruiting
23
Tours University Hospital
Tours, France, 37000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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