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INFINITY - Effect of interferon gamma as a treatment for post-aggressive immunosuppression in intensive care units, a randomized Bayesian double-blind controlled trial versus placebo
EU CTIS ID: 2023-506725-11-00
What this study is testing
To evaluate the efficacy of subcutaneous administration of recombinant human interferon gamma 1-b (IFNy) in improving the number of days alive without mechanical ventilation at D28(or when leaving intensive care) compared with a placebo in patients admitted to intensive care, with a high severity score (SOFA of the first 24 hours post-admission ≥ 6) and a biological criterion of immunosuppression (mHLA-DR < 8000 AB/C) measured between days 5 and 10 of their admission to intensive care.
- 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
- Patient ≥ 18 years old
- SOFA score for first 24 hours post-admission ≥ 6
- Mechanically ventilated at the time of inclusion (non-invasive ventilation (NIV) and high-flow nasal oxygen excluded)
- mHLA-DR< 8,000 AB/C measured between the 5th and 10th day after admission to the intensive care unit
- Patient affiliated to a social security scheme
- Written consent (relative/trusted person)
You likely can't join if
- Patient with estimated life expectancy of less than 3 months
- People under court protection and protected adults
- Patients with a predicted remaining stay in intensive care < 72 hours
- Patient with pre-existing immunosuppression: solid cancer active or in remission for < 5 years, active hemopathy or in remission for < 5 years, systemic disease (including in the absence of specific treatment), solid organ transplant or marrow allograft patient, patient suffering from a HIV infection
- Patients with an expected prolonged duration of mechanical ventilation: comatose or vegetative patients (admission for severe stroke with Glasgow score < 8, patient resuscitated from an arterial stroke,) patients with tracheotomy for ENT problems, patients suffering from muscular disease (e.g. myopathy), patients on long-term mechanical ventilation
- Pregnant or breast-feeding women
See the full eligibility criteria
- Patient ≥ 18 years old
- SOFA score for first 24 hours post-admission ≥ 6
- Mechanically ventilated at the time of inclusion (non-invasive ventilation (NIV) and high-flow nasal oxygen excluded)
- mHLA-DR< 8,000 AB/C measured between the 5th and 10th day after admission to the intensive care unit
- Patient affiliated to a social security scheme
- Written consent (relative/trusted person)
- Patient with estimated life expectancy of less than 3 months
- People under court protection and protected adults
- Patients with a predicted remaining stay in intensive care < 72 hours
- Patient with pre-existing immunosuppression: solid cancer active or in remission for < 5 years, active hemopathy or in remission for < 5 years, systemic disease (including in the absence of specific treatment), solid organ transplant or marrow allograft patient, patient suffering from a HIV infection
- Patients with an expected prolonged duration of mechanical ventilation: comatose or vegetative patients (admission for severe stroke with Glasgow score < 8, patient resuscitated from an arterial stroke,) patients with tracheotomy for ENT problems, patients suffering from muscular disease (e.g. myopathy), patients on long-term mechanical ventilation
- Pregnant or breast-feeding women
- Patients on immunosuppressive therapy, including long-term corticosteroid therapy (>2.5mg/d prednisone equivalent)
- Patients with severe hepatic or renal insufficiency
- Patient included in another interventional clinical trial
- Contraindication of Imukin (hypersensitivity to interferon gamma-1b or known hypersensitivity to related products, such as another interferon)
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, 18-64 years, 65+ 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.