Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression
NCT ID: NCT06774235
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
326 participants
INTERVENTIONAL
2025-07-09
2028-10-09
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Interferon-gamma
Injections of Interferon gamma-1b are sub-cutaneous and preferably in the deltoid region left or right or on the anterior part of the thigh.
5 injections between day 1 and day 9
Interferon Gamma 1-b
injection of interferon gamma 1-b
Placebo
The comparative treatment will be a placebo, consisting in 0.5 ml of 0.9% sodium chloride solution only (same volume for interferon gamma-1b)
Placebo
Injection of placebo in the same condition of experimental traitment
Interventions
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Interferon Gamma 1-b
injection of interferon gamma 1-b
Placebo
Injection of placebo in the same condition of experimental traitment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Limoges
OTHER
Responsible Party
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Locations
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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
Limoges University Hospital
Limoges, , France
Lyon Civils Hospices
Lyon, , France
APHM
Marseille, , France
Melun Hospital
Melun, , France
Nancy University Hospital
Nancy, , France
Nantes University Hospital
Nantes, , France
Orléans Hospital
Orléans, , France
APHP - Laroiboisière
Paris, , France
Aphp - Hegp
Paris, , France
APHP - Cochin
Paris, , France
Rennes University Hospital
Rennes, , France
Strasbourg University Hospital
Strasbourg, , France
Tours University Hospital
Tours, , France
Countries
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Facility Contacts
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Other Identifiers
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2024-516780-93-00
Identifier Type: CTIS
Identifier Source: secondary_id
87RI24_0040 (PLATINIUM)
Identifier Type: -
Identifier Source: org_study_id
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