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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Limoges
NOT_YET_RECRUITING
Limoges
Hôpital Edouard Herriot - Médecine intensive - réanimation
NOT_YET_RECRUITING
Lyon
Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire
RECRUITING
Lyon
Service de reanimation chirurgicale Hopital Croix-Rousse
NOT_YET_RECRUITING
Lyon
Service de reanimation médicale hôpital de la Croix-Rousse
RECRUITING
Lyon
Service d'anesthésie-réanimation, unité de réanimation chirurgicale Picard
NOT_YET_RECRUITING
Nancy
Médecine intensive- Réanimation
NOT_YET_RECRUITING
Paris
Service d'Anesthésie-réanimation-médecine intensive Hôpital Lyon Sud
RECRUITING
Pierre-bénite
Département Anesthésie-Réanimation
NOT_YET_RECRUITING
Saint-etienne
Contact Information
Primary
Anne-Claire LUKASZEWICZ, Pr
anne-claire.lukaszewicz@chu-lyon.fr
472 11 13 27
Backup
Camille BOUCHENY
Camille.boucheny@chu-lyon.fr
4 26 73 27 39
Time Frame
Start Date: 2023-06-30
Estimated Completion Date: 2025-07-30
Participants
Target number of participants: 132
Treatments
Experimental: Interferon gamma treatment
Interferon gamma treatment (100 micrograms /day during 5 days)
Placebo_comparator: Placebo
The comparator drug (placebo) is an injectable solution of sodium chloride 0.9%
Related Therapeutic Areas
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov