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Compares treatment options for Post-aggressive Immunosuppression
Official title Effect of Interferon Gamma as a Treatment for Post-aggressive Immunosuppression in Intensive Care Units, a Randomized Bayesian Double-blind Controlled Trial Versus Placebo
ClinicalTrials.gov ID: NCT06694740
What this study is testing
What is Interferon Gamma 1-b?
Interferon Gamma 1-b is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for post-aggressive immunosuppression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The vast majority of serious clinical situations leading to intensive care (septic shock, polytrauma, acute cerebral aggression, major surgery) are characterized by significant systemic inflammation. Recently, the existence of a common immune response pattern to acute aggression has been demonstrated, and with it the existence of a phenomenon known as post-aggressive immunosuppression (PAIS).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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
You likely can't join if
- Patient with estimated life expectancy of less than 3 months
- 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...
- Patients with an expected prolonged duration of mechanical ventilation: comatose or vegetative patients (admission for severe stroke with Glasgow...
- Pregnant or breast-feeding women
- Contraindication of Imukin (hypersensitivity to interferon gamma-1b or known hypersensitivity to related products, such as another interferon)
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
- 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...
- 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...
- Pregnant or breast-feeding women
- Contraindication of Imukin (hypersensitivity to interferon gamma-1b or known hypersensitivity to related products, such as another interferon)
- 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 treatment clinical trial
- People under court protection and protected adults
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.