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RECRUITING
NCT05843786
PHASE3

Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

Clinical presentation of patients after severe injury such as a severe infection, trauma or extensive burns is characterized by the simultaneous occurrence of dysregulation of the initial inflammatory response and immunosuppression associating quantitative and functional alterations of innate and adaptive immune cells. These acquired immune dysfunctions have been associated with an increased susceptibility to nosocomial infections, foremost among which are ventilator-associated pneumonia (VAP). Despite the implementation of a set of preventive measures, the incidence of these VAP remains high in intensive care, with rates in Europe of 1.5% per day of ventilation. Post-aggressive immunosuppression is characterized by the decrease in the expression of HLA-DR (belonging to the type II major histocompatibility complex, MHC-II) on the surface of monocytes (mHLA-DR). The administration of interferon gamma (IFNγ) can restore the level of mHLA-DR and may possibly improve the prognosis as an adjuvant therapy associated to antibiotics. However, the level of proof of this therapeutic strategy is low, limited to small cohorts of patients, or clinical studies without prior immunodepression assessment. The objective of this study is to conduct a randomized, double-blind, placebo-controlled superiority trial to assess the effect of IFNγ administration on the duration of mechanical ventilation following the first episode of VAP in patients having an HLA-DR \< 8000 AB/C All reported data about recombinant human IFNγ 1b for the control of secondary infections in patients with septic shock used the dose of 100 micrograms per day by subcutaneous route for 3 to 5 days . At this dose, no retrospective study has reported any serious adverse effects and recombinant human IFNγ 1b allows an increase in monocyte membrane expression of mHLA-DR.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2023-06-30

Completion Date

2027-07-30

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DRUG

Interferon gamma

Daily subcutaneous administration of Interferon gamma during 5 days

DRUG

Placebo

Placebo during 5 days

Locations (9)

CHU Limoges

Limoges, France

Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire

Lyon, France

Service de reanimation chirurgicale Hopital Croix-Rousse

Lyon, France

Service de reanimation médicale hôpital de la Croix-Rousse

Lyon, France

Hôpital Edouard Herriot - Médecine intensive - réanimation

Lyon, France

Service d'anesthésie-réanimation, unité de réanimation chirurgicale Picard

Nancy, France

Médecine intensive- Réanimation

Paris, France

Service d'Anesthésie-réanimation-médecine intensive Hôpital Lyon Sud

Pierre-Bénite, France

Département Anesthésie-Réanimation

Saint-Etienne, France