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NCT06774235 | NOT YET RECRUITING | Sustained Immunosuppression

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

University Hospital, Limoges

Brief Summary:

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

Condition or disease

Sustained Immunosuppression

Intervention/treatment

Interferon Gamma 1-b

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 326 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression: a Randomized Trial
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2028-09-01
Estimated Study Completion Date : 2028-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Adult patient hospitalized in the ICU for at least 1 week
  • * Expected length of stay in the ICU greater than 1 week 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
  • * Consent from family members or patient
Exclusion Criteria
  • * Ongoing secondary infection at 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 (see appendix 1)
  • * Pregnancy or breast feeding
  • * Subjects with a history hypersensitivity to interferon gamma or excipient 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)
Prevention of Secondary Infections by Interferon Gamma in ICU-acquired Sustained Immune-suppression

Location Details

NCT06774235

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Angers university hospial

Angers, France, 49100

Not yet recruiting

France,

Argenteuil Hospital

Argenteuil, France, 95107

Not yet recruiting

France,

Franche-Comté North Hospital

Belfort, France, 90015

Not yet recruiting

France,

Brive Hospital

Brive La Gaillarde, France, 19100

Not yet recruiting

France,

Chalon sur Saone Hospital

Chalon-sur-Saone, France, 71100

Not yet recruiting

France,

Dijon University Hospital

Dijon, France, 21000

Not yet recruiting

France,

APHP - Raymond Poincaré

Germ, France, 92380

Not yet recruiting

France,

Versailles Hospital

Le Chesnay, France, 78157

Not yet recruiting

France,

Le Mans Hospital

Le Mans, France, 72000

Not yet recruiting

France,

Limoges University Hospital

Limoges, France, 87042

Not yet recruiting

France,

Lyon Civilians Hospices

Lyon, France, 69002

Not yet recruiting

France,

APHM

Marseille, France, 13915

Not yet recruiting

France,

Melun Hospital

Melun, France, 77000

Not yet recruiting

France,

Nancy University Hospital

Nancy, France, 54035

Not yet recruiting

France,

Nantes University Hospital

Nantes, France, 44000

Not yet recruiting

France,

Orléans Hospital

Orleans, France, 45100

Not yet recruiting

France,

APHP - Laroiboisière

Paris, France, 75010

Not yet recruiting

France,

Question

Paris, France, 75014

Not yet recruiting

France,

APHP - Cochin

Paris, France, 75015

Not yet recruiting

France,

Rennes University Hospital

Rennes, France, 35000

Not yet recruiting

France,

Strasbourg University Hospital

Strasbourg, France, 67091

Not yet recruiting

France,

Tours University Hospital

Tours, France, 37000