Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05843786
Study type	Interventional
Source	Hospices Civils de Lyon
Contact	Anne-Claire LUKASZEWICZ, Pr
Phone	472 11 13 27
Email	anne-claire.lukaszewicz@chu-lyon.fr
Status	Recruiting
Phase	Phase 3
Start date	June 30, 2023
Completion date	July 30, 2025

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06370598` - Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia	Phase 1/Phase 2
Terminated	`NCT02806141` - Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates	Phase 3
Completed	`NCT01765530` - Efficacy Study of a Novel Device to Clean the Endotracheal Tube	N/A
Completed	`NCT00521677` - Comparison Between Two Methods of Oral Care on the Incidence of VAP	N/A
Completed	`NCT00529776` - Prophylaxis of Ventilator Associated Pneumonia by Continuous Lateral Rotation Therapy	N/A
Completed	`NCT03401463` - Assesment of the Endotracheal Tube Cuff Pressure Values in ICU Pateints Before and After Training Seminar	N/A
Completed	`NCT02950519` - Endotracheal Tube Cuff Pressures in Ventilated Patients	N/A
Completed	`NCT01875692` - Can we Better Understand the Development of VAP and Eventually Predict and Prevent it?	N/A
Completed	`NCT00515034` - A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia	Phase 2
Recruiting	`NCT05117125` - Biomarkers for Ventilator-associated Pneumonia
Completed	`NCT04755972` - Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2	N/A
Terminated	`NCT02940626` - Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.	Phase 2
Completed	`NCT01577862` - Colistin and Rifampicin for MDR-Acinetobacter	Phase 3
Completed	`NCT00572559` - Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus	Phase 4
Withdrawn	`NCT04566172` - Preoperative Optimization to Improve Functional Status	N/A
Recruiting	`NCT04215692` - Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients	N/A
Completed	`NCT03816956` - Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301	Phase 3
Active, not recruiting	`NCT01123681` - Intubation and Extubation Over 48 Hours Mechanical Ventilation	N/A
Recruiting	`NCT04839653` - Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria	N/A
Recruiting	`NCT03527992` - Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms