Actively Recruiting
Human Recombinant Interferon Gamma in the Treatment of Ventilator-Acquired Pneumonia in ICU Patients
Led by Hospices Civils de Lyon · Updated on 2025-11-21
132
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
After a severe injury such as a serious infection, trauma, or extensive burns, patients often experience immune system problems that increase their risk for hospital-acquired infections like ventilator-associated pneumonia (VAP). This trial evaluates the use of interferon gamma to help improve immune function in intensive care patients who develop VAP and have low levels of a specific immune marker called monocyte HLA-DR. The study is a randomized, double-blind, placebo-controlled Phase 3 trial aimed at assessing whether interferon gamma can affect the duration of mechanical ventilation after VAP onset. Participants will receive either interferon gamma or a placebo. The interferon gamma is given as a 100 microgram dose daily by injection under the skin for 5 days. The placebo is a saltwater solution given in the same way. This treatment period is designed to restore immune function and potentially improve recovery outcomes. The study compares these two groups to see if interferon gamma impacts the length of time patients need mechanical ventilation. During the study, patients will be closely monitored for their duration on mechanical ventilation, survival in intensive care, microbiological infection status, length of stay in ICU and hospital, recurrence of infections, and immune system markers such as monocyte HLA-DR expression and white blood cell counts. Economic efficiency of the interferon gamma treatment will also be evaluated. Participation involves assessments up to 28 days from the initial VAP diagnosis with safety and effectiveness measures tracked throughout.
CONDITIONS
Brief Title
Human Recombinant Interferon Gamma in the Treatment of Ventilator-acquired Pneumonia in ICU Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients hospitalized in intensive care unit
- On mechanical ventilation for more than 5 days
- Experiencing a first episode of ventilator-associated pneumonia with a CPIS score greater than 6
- Treated with antibiotics for less than 24 hours
- Monocyte HLA-DR level less than 8000 AB/C
- Written informed consent signed by patient's trusted support person or emergency certificate agreement
- Membership of a social security scheme
You will not qualify if you...
- Unable to receive first study treatment dose within 48 hours of starting antibiotics
- Receiving noradrenaline greater than 0.25 mcg/kg/min
- Immunosuppression due to cancer chemotherapy in last 3 months, metastatic disease, hematological disease, organ transplant, HIV infection, or immunosuppressive therapy
- Head or cervical spine trauma affecting ventilation duration
- Richmond Agitation-Sedation Scale score of 0 or 1
- FiO2 less than 40%, PEEP less than 5 cmH2O
- Respiratory frequency to tidal volume ratio less than 105
- Effective cough and response to commands
- Noradrenaline less than 0.2 mcg/kg/min
- Cardiocirculatory arrest
- Burn patient
- Cirrhosis with Child B or C score
- Aspergillus infection
- Refusal to participate
- Participation in other interventional research with exclusion period
- Lack of social coverage
- Under curatorship or guardianship
- Pregnant or breastfeeding women
- ICU admission for SARS-Cov2 pneumonia
- Known allergy to latex or hypersensitivity to interferon gamma or related substances
- Chronic heart disease with ejection fraction less than 45%
- Major liver impairment or thrombocytopenia
- Severe chronic renal failure
- Respiratory failure requiring home oxygen
- Under court protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 days
Participants receive daily subcutaneous administration of Interferon gamma or placebo for 5 days.
5 daily visits (in-person)
Trial Site Locations
Total: 9 locations
1
CHU Limoges
Limoges, France
Not Yet Recruiting
2
Service civilo-militaire d'Anesthésie-Réanimation et Médecine Périopératoire
Lyon, France, 69003
Actively Recruiting
3
Service de reanimation chirurgicale Hopital Croix-Rousse
Lyon, France, 69004
Not Yet Recruiting
4
Service de reanimation médicale hôpital de la Croix-Rousse
Lyon, France, 69004
Actively Recruiting
5
Hôpital Edouard Herriot - Médecine intensive - réanimation
Lyon, France
Not Yet Recruiting
6
Service d'anesthésie-réanimation, unité de réanimation chirurgicale Picard
Nancy, France, 54511
Not Yet Recruiting
7
Médecine intensive- Réanimation
Paris, France, 75014
Not Yet Recruiting
8
Service d'Anesthésie-réanimation-médecine intensive Hôpital Lyon Sud
Pierre-Bénite, France, 69395
Actively Recruiting
9
Département Anesthésie-Réanimation
Saint-Etienne, France, 42055
Not Yet Recruiting
Research Team
A
Anne-Claire LUKASZEWICZ, Pr
C
Camille BOUCHENY
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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