Using interferon gamma to treat pneumonia in ICU patients on ventilators
Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients
This study is testing if a treatment called interferon gamma can help improve recovery for adults on ventilators who have pneumonia while in the ICU.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | chemotherapy, Prednisone |
| Locations | 9 sites (Limoges and 8 other locations) |
| Trial ID | NCT05843786 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of human recombinant interferon gamma to treat ventilator-associated pneumonia (VAP) in adult patients who have been hospitalized in intensive care units and are on mechanical ventilation for over five days. The study aims to restore immune function by increasing the expression of HLA-DR on monocytes, which may improve patient outcomes. Participants will receive either interferon gamma or a placebo, and their responses will be monitored to assess the effectiveness of the treatment.
Who should consider this trial
Good fit: Ideal candidates are adult ICU patients on mechanical ventilation for more than five days who have a first episode of VAP and meet specific immunological criteria.
Not a fit: Patients with severe immunosuppression or those who have received certain recent treatments, such as chemotherapy or organ transplantation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence and severity of ventilator-associated pneumonia in critically ill patients.
How similar studies have performed: While the approach of using interferon gamma in this context is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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) * Lack of social coverage * Patient under curatorship or guardianship * Pregnant or breastfeeding women * Patient admitted to intensive care for SARS-Cov2 pneumonia * Known allergy to latex * Hypersensitivity to the active substance (interferon gamma-1b) or known hypersensitivity to related products, such as another interferon, or to any of the following excipients: Mannitol, Disodium succinate hexahydrate, Succinic acid, polysorbate 20 * Existence of chronic heart disease with FeVG\<45% * Major hepatic impairment (total bilirubin\>60 mg/L or 102 mcmol/L, equivalent to 3 SOFA points) * thrombocytopenia \<50000/mm3 (equivalent to 3 SOFA points) AST and/or ALT \> 5N Lipase \> 3N Severe chronic renal failure (creatinine clearance MDRD\< 10 ml/min/1.73m2) * Thrombocytopenia \<50,000/mm3 (equivalent to 3 SOFA points) * Respiratory failure requiring home oxygen therapy * Persons under court protection
Where this trial is running
Limoges and 8 other locations
- CHU Limoges — Limoges, France (Not_yet_recruiting)
- Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire — Lyon, France (Recruiting)
- Service de reanimation chirurgicale Hopital Croix-Rousse — Lyon, France (Not_yet_recruiting)
- Service de reanimation médicale hôpital de la Croix-Rousse — Lyon, France (Recruiting)
- Hôpital Edouard Herriot - Médecine intensive - réanimation — Lyon, France (Not_yet_recruiting)
- Service d'anesthésie-réanimation, unité de réanimation chirurgicale Picard — Nancy, France (Not_yet_recruiting)
- Médecine intensive- Réanimation — Paris, France (Not_yet_recruiting)
- Service d'Anesthésie-réanimation-médecine intensive Hôpital Lyon Sud — Pierre-Bénite, France (Recruiting)
- Département Anesthésie-Réanimation — Saint-Etienne, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Anne-Claire LUKASZEWICZ, Pr — Hospices Civils de Lyon
- Study coordinator: Anne-Claire LUKASZEWICZ, Pr
- Email: anne-claire.lukaszewicz@chu-lyon.fr
- Phone: 472 11 13 27
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.