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

Официальное название

Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression: a Randomized Trial

Обзор

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

Вмешательства

• Препарат Interferon Gamma 1-b
  injection of interferon gamma 1-b
• Препарат Placebo
  Injection of placebo in the same condition of experimental traitment

Первичные конечные точки

• Incidence of secondary infection episodes [Срок оценки: Day 90]

Вторичные конечные точки (11)

• Cause of mortality of participant [Срок оценки: Day 90]
• Length of stay in the ICU and in the hospital [Срок оценки: Day 90]
• Antibiotic consumption [Срок оценки: Day 90]
• Biological immune restoration [Срок оценки: Day 10]
• Healthcare costs [Срок оценки: Day 90]
• Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) [Срок оценки: Day 90]
• Antifungal consumption [Срок оценки: Day 90]
• Antifungal consumption [Срок оценки: Day 90]
• Antifungal consumption [Срок оценки: Day 90]
• Antibiotic consumption [Срок оценки: Day 90]
• Antibiotic consumption [Срок оценки: Day 90]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Франция · 23 центра

• Angers university hospial — Angers
• Argenteuil hospital — Argenteuil
• Franche-comté north Hospital — Belfort
• Brive Hospital — Brive-la-Gaillarde
• Chalon sur saone Hospital — Chalon-sur-Saône
• Dijon University Hospital — Dijon
• APHP - Raymond Poincaré — Garches
• Versailles Hospital — Le Chesnay
• … и ещё 15 центров

Публикации

• Hernandez Padilla AC, Daix T, Hotchkiss RS, Monneret G, Tadie JM, Jeannet R, Plateker O, Vaidie J, Durand-Zaleski I, Magne J, Giraudeau B, Francois B. Prevention of secondary infections by interferon-gamma in ICU-acquired sustained immune suppression in France: study protocol of the PLATINIUM randomised trial. BMJ Open. 2026 Jan 27;16(1):e106790. doi: 10.1136/bmjopen-2025-106790. PMID 41592843

Идентификаторы

NCT: NCT06774235 · 87RI24_0040 (PLATINIUM) · 2024-516780-93-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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