RecruitingPHASE2, PHASE3INTERVENTIONAL

Effect of Interferon Gamma as a Treatment for Post-aggressive Immunosuppression in Intensive Care Units, a Randomized Bayesian Double-blind Controlled Trial Versus Placebo

This research is investigating if a drug called Interferon Gamma 1-b can help critically ill adult patients in intensive care units (ICU). Many severe illnesses that land people in ICU can temporarily weaken their immune system, a condition known as post-aggressive immunosuppression (PAIS). When the immune system is weak, patients are more likely to get new infections and face other complications. Currently, there isn't a proven treatment for PAIS. This study is testing Interferon Gamma 1-b to see if it can help strengthen the immune system in these patients, potentially reducing further infections and improving their recovery. The study compares Interferon Gamma 1-b to a dummy treatment (placebo) to see if it makes a difference.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

170

Start

12 Jan 2026

Estimated completion

01 Apr 2028

Post-aggressive Immunosuppression Adult Patients Admitted to Intensive Care With Initial Severity (SOFA of the First 24 Hours Post-admission ≥ 6 Adult Under Mechanical Ventilation, and Presenting an mHLA-DR Less Than 8,000AB/C

What is this study about?

When people get very sick and need intensive care, like after a serious accident, a big operation, or a major infection, their body goes through a lot of stress. This stress often causes a powerful reaction, and sometimes, as a way to protect itself, the body's immune system can become temporarily much weaker. This weakening is what we call post-aggressive immunosuppression, or PAIS.

Now, a weakened immune system might sound scary, and it can be, because it makes patients more vulnerable to new infections and can make their recovery more difficult and lengthy. Doctors can identify PAIS by looking at specific markers in the blood. Currently, there's no standard treatment specifically designed to help people recover from PAIS.

This study aims to discover if a medication called Interferon Gamma 1-b can help boost the immune system in these very sick patients. If successful, this could reduce the risk of further infections and help patients recover better and quicker from their critical illness. The study is designed to compare this medication with a 'dummy' treatment (placebo) to ensure any observed benefits are truly due to the medicine.

Key takeaways

Tests a drug (Interferon Gamma 1-b) to boost weakened immune systems in critically ill adults.
Aims to reduce infections and improve recovery in intensive care patients.
Compares the drug against a dummy treatment (placebo).
Requires participants to be over 18, critically ill, and on a breathing machine with a weakened immune system.
Participation is voluntary, and you can withdraw at any time.
Potential benefits include better immune function; potential risks involve drug side effects.

Who may be eligible?

This study is looking for adults aged 18 or over who are currently in intensive care.

To be considered, you would need to be very unwell, typically indicated by a specific score (called a SOFA score) and be on a breathing machine (mechanical ventilation). Your eligibility would also depend on a blood test showing that your immune system is currently weakened (a low mHLA-DR level) between day 5 and day 10 of your ICU stay.

However, some conditions would mean you couldn't take part. This includes if your doctors expect you to recover very quickly or if you have a very short life expectancy. You also couldn't join if you have a pre-existing condition that affects your immune system (like certain cancers, HIV, or organ transplants), if you're pregnant or breastfeeding, if you have severe liver or kidney problems, or if you're already taking certain medications that suppress your immune system.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently in intensive care and on a breathing machine?
Has your doctor mentioned your immune system might be weakened?
Do you have severe liver or kidney problems, or certain long-term illnesses like specific cancers or HIV?
Are you pregnant or breastfeeding?
Are you currently taking strong medications that suppress your immune system (like high-dose steroids)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive either the study drug (Interferon Gamma 1-b) or a dummy treatment (placebo). Neither you nor your doctors will know which one you are receiving. The study involves regular monitoring of your health, including blood tests, to see how your immune system is responding and to keep an eye on any side effects. The exact duration of your participation will depend on your recovery, but the study will monitor your progress while you are in intensive care and beyond for any follow-up assessments. Your care team will explain all the specific procedures and the overall timeline if you are eligible.

Potential risks and benefits

Participating in this study might offer the potential benefit of helping your immune system recover from a weakened state, which could reduce your risk of further infections and improve your overall recovery from critical illness. This is why the research is being done, as there is currently no proven treatment. However, as with any medication, Interferon Gamma 1-b may have side effects, and some people may experience no benefit from taking part. You will be closely monitored for any reactions or changes in your health. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Dr de Roquetaillade
Verified postcode
Paris, France· Recruiting
Pr Dépret
Verified postcode
Paris, France· Recruiting

Common questions

What is 'post-aggressive immunosuppression' (PAIS)?

It's when your immune system becomes weaker after a severe illness or injury, making you more prone to infections.

What is Interferon Gamma 1-b?

It's a medication being tested to see if it can help strengthen a weakened immune system in very sick patients.

Will I know if I'm getting the drug or a dummy treatment?

No, neither you nor your doctors will know. This is called 'double-blind' and helps ensure fair results.

Can I stop participating in the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect the medical care you receive.

Who is funding this research?

The study document doesn't specify the funding source, but clinical trials are usually funded by research grants, pharmaceutical companies, or government agencies.

How to find out more

Charles De ROQUETAILLADE, MD

charles.de-roquetaillade@aphp.fr 01 49 95 55 68 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.