Using interferon gamma to treat pneumonia in ICU patients on ventilators

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire
  Lyon, France Recruiting
• Service de reanimation médicale hôpital de la Croix-Rousse
  Lyon, France Recruiting
• Médecine intensive- Réanimation
  Paris, France Recruiting
• Service d'Anesthésie-réanimation-médecine intensive Hôpital Lyon Sud
  Pierre-Bénite, France Recruiting
• CHU Limoges
  Limoges, France Not yet recruiting
• Service de reanimation chirurgicale Hopital Croix-Rousse
  Lyon, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.