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Human recombinant interferon gamma in the treatment of ventilator-acquired pneumonia in ICU patients. IGNORANT study
EU CTIS ID: 2022-502229-16-00
What this study is testing
To evaluate the efficacy of recombinant human interferon gamma in reducing the duration of mechanical ventilation during the first episode of VAP in a population of patients treated in intensive care in addition to antibiotic treatment and having an mHLA-DR < 8000AB/C.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- adult patients hospitalized in intensive care unit
- under mechanical ventilation for more than 5 days
- having a first episode of VAP (with a CPIS score >6)
- 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
- Affiliation to a social security scheme
You likely can't join if
- Noradrénaline > 0.25 mcg/kg/min
- 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)
- AST and/or ALT > 5N
- Lack of social coverage
- Lipase > 3N
- Severe chronic renal failure (creatinine clearance MDRD< 10 ml/min/1.73m2)
See the full eligibility criteria
- adult patients hospitalized in intensive care unit
- under mechanical ventilation for more than 5 days
- having a first episode of VAP (with a CPIS score >6)
- 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
- Affiliation to a social security scheme
- Noradrénaline > 0.25 mcg/kg/min
- 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)
- AST and/or ALT > 5N
- Lack of social coverage
- Lipase > 3N
- Severe chronic renal failure (creatinine clearance MDRD< 10 ml/min/1.73m2)
- 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 other interferons, or to any of the following excipients: Mannitol, Disodium succinate hexahydrate, Succinic acid, polysorbate 20
- thrombocytopenia <50000/mm3 (equivalent to 3 SOFA points)
- 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)
- impossibility of administering the first dose of study treatment within 48 hours after the start of antibiotic therapy (antibiotic therapy for VAP)
- Respiratory failure requiring home oxygen therapy
- People placed under judicial protection
- 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 foreseeable impact on the duration of mechanical ventilation (left to the investigator's judgement)
- Cardiocirculatory arrest
- Burn patient
- Cirrhosis with Child B or C score
- Infection with Aspergillus spp.
- Refusal to participate
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.