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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Pneumonia, Ventilator-Associated

In brief

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 facts

Study ID: NCT05843786
Run by: Hospices Civils de Lyon
People needed: 132
Starts: 2023-06-30
Expected to finish: 2027-07-30
Last updated by the study team: 2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

adult patients hospitalized in intensive care unit
under mechanical ventilation for more than 5 days
having a first episode of VAP (with a Clinical Pulmonary Infectious Score (CPIS score) >6)
treated with antibiotics for less than 24 hours
with monocyte HLA-DR < 8000 AB/C
written informed consent signed by the patient's trusted support person, or in the absence of the patient's representative and taking into account the agreement of the relative obtained by telephone emergency certificate completed and signed by the investigator
membership of a social security scheme

You may not qualify if…

inability to administer the first dose of treatment in the study within 48 hours of the start of antibiotic therapy (antibiotic therapy for VAP)
Noradrenaline > 0.25 mcg/kg/min
Immunosuppression, defined by:
solid tumor with chemotherapy in the last 3 months
progressive metastatic disease
hematological disease
solid organ transplantation
HIV infection (AIDS stage or not)
corticosteroid therapy at any dose for more than 3 months
≥ 1 mg/kg of Prednisone equivalent for more than 7 days
immunosuppressive therapy
Head and/or cervical spine trauma : with a predictable impact on the duration of mechanical ventilation (left to the investigator's judgement), the investigator will assess whether the patient meets the following neurological criteria for extubation during their recovery:
A level of consciousness assessed as 0 or 1 on the Richmond Agitation-Sedation Scale (RASS)
FiO2 <40%
PEEP level <5 cmH2O
A FR/Vt ratio <105
Effective cough
Response to simple commands
Administration of noradrenaline < 0.2 mcg/kg/min
Cardiocirculatory arrest
Burn patient
Cirrhosis with Child B or C score
Infection with Aspergillus spp.
Refusal to participate
Patient participating in another interventional research in progress or including an exclusion period still in progress at pre-inclusion (excluding interventional research of 2° not interfering with the endpoints of the study according to the judgment of the principal investigator)

Where it is running

Service de reanimation médicale hôpital de la Croix-Rousse — Lyon, France (enrolling)
Médecine intensive- Réanimation — Paris, France (enrolling)
Service d'Anesthésie-réanimation-médecine intensive Hôpital Lyon Sud — Pierre-Bénite, France (enrolling)
Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire — Lyon, France (enrolling)
CHU Limoges — Limoges, France
Département Anesthésie-Réanimation — Saint-Etienne, France
Service de reanimation chirurgicale Hopital Croix-Rousse — Lyon, France
Hôpital Edouard Herriot - Médecine intensive - réanimation — Lyon, France
Service d'anesthésie-réanimation, unité de réanimation chirurgicale Picard — Nancy, France

Full record on ClinicalTrials.gov

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