In short
Currently, there is 1 ongoing clinical trial investigating treatments for immunosuppression following severe illness in intensive care patients. This trial is testing recombinant human interferon gamma 1b, a protein designed to boost immune system function, in patients who have developed weakened immunity after critical illness or injury.
Clinical trial locations
Study on the Effect of Recombinant Human Interferon Gamma 1b for Patients with Post-Aggressive Immunosuppression in Intensive Care
This clinical trial is investigating a treatment for patients who develop weakened immune systems after being critically ill in intensive care units. The condition, known as post-aggressive immunosuppression, occurs when the body's ability to fight infections becomes reduced following severe illness, surgery, or trauma.
Main inclusion criteria:
- Patients must be 18 years old or older
- Must have a SOFA score of 6 or higher within the first 24 hours of admission, indicating severe illness
- Must require mechanical ventilation (a machine to help with breathing)
- Must have an mHLA-DR level of less than 8,000 AB/C measured between day 5 and day 10 after admission, which indicates weakened immune function
- Must have health insurance or social security coverage
- Written consent must be provided by a relative or trusted person
Main exclusion criteria:
- Patients whose immune systems are not weakened after severe illness
- Patients with a SOFA score below 6 in the first 24 hours
- Patients with mHLA-DR levels of 8,000 AB/C or higher
- Patients not admitted to intensive care
- Vulnerable populations requiring special protection
Focus and goal of the trial:
The primary goal is to determine whether recombinant human interferon gamma 1b can increase the number of days patients are alive without needing mechanical ventilation by day 28 or upon leaving intensive care. The study will also monitor various immune system markers and inflammation levels at specific intervals throughout the treatment period. Researchers will track infection rates, antibiotic use, and mortality rates at 28 and 90 days to assess the treatment's effectiveness.
Investigational drug:
The trial is testing recombinant human interferon gamma 1b, a protein that helps boost immune system activity. It is administered as an injection under the skin over a period of up to three days. This medication works by enhancing the body's immune response, potentially helping patients fight infections more effectively and recover faster from their weakened immune state.
The study uses a double-blind, randomized design, meaning neither patients nor healthcare providers know who receives the actual treatment versus a placebo. This approach helps ensure unbiased results. The trial is expected to conclude by October 2027.
Summary
Currently, there is one clinical trial actively recruiting patients with post-aggressive immunosuppression in France. This trial focuses specifically on patients in intensive care units who have developed weakened immune systems following severe illness or injury. The study is investigating recombinant human interferon gamma 1b, an immunomodulator designed to restore immune function and reduce the time patients need mechanical ventilation support. The trial represents an important step in developing treatment options for this serious complication of critical illness, which can leave patients vulnerable to infections and other health challenges during recovery.
