Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients (NCT05843786) | Clinical Trial Compass
RecruitingPhase 3
Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients
France132 participantsStarted 2023-06-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
duration of mechanical ventilation assessed from the first day of VAP diagnosis