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Study on Recombinant Human Interferon Gamma 1b and Sodium Chloride for Treating Ventilator-Associated Pneumonia in ICU Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of ventilator-acquired pneumonia, a type of lung infection that occurs in patients who are on mechanical ventilators in the intensive care unit (ICU). The treatment being tested is called recombinant human interferon gamma 1b, which is a type of protein that can help the immune system fight infections. This study aims to see if this treatment can reduce the time patients need to be on a ventilator during their first episode of this pneumonia, in addition to the antibiotics they are already receiving.

Participants in the study will receive either the recombinant human interferon gamma 1b or a placebo, which is a substance with no active medication. The study will monitor how long patients remain on mechanical ventilation and other factors such as the length of stay in the ICU and hospital, the occurrence of any additional episodes of pneumonia, and overall survival rates in the ICU. The study will also look at how the treatment affects certain immune system markers in the blood.

The trial will last for a period of time during which patients will be closely observed to gather data on the effectiveness and safety of the treatment. The goal is to determine if recombinant human interferon gamma 1b can provide a significant benefit in treating ventilator-acquired pneumonia in ICU patients. This research could potentially lead to improved treatment options for patients suffering from this serious condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures involved. You will need to provide written informed consent, which will be signed by your trusted support person.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are an adult patient in the intensive care unit, have been on mechanical ventilation for more than 5 days, and are experiencing your first episode of ventilator-acquired pneumonia (VAP).
Step 3
Treatment initiation
If eligible, you will begin treatment with recombinant human interferon gamma 1b. This medication is administered as a subcutaneous injection, which means it is injected under the skin. The dosage is 2 x 10⁶ UI (0.1 mg).
Step 4
Ongoing treatment
The treatment will continue alongside your antibiotic therapy. The frequency and duration of the injections will be determined by the study protocol and your medical team.
Step 5
Monitoring and assessments
Throughout the study, your health will be closely monitored. This includes checking the number of days you are free from mechanical ventilation, monitoring for any new episodes of VAP, and assessing the evolution of certain blood markers.
Step 6
End of study participation
Your participation in the study will conclude after a specified period, typically by day 28. At this point, a final assessment will be conducted to evaluate the outcomes of the treatment.

Who can join the trial?

7 criteria

Adult patients who are in an intensive care unit (ICU).
Patients who have been on a breathing machine (mechanical ventilation) for more than 5 days.
Patients experiencing their first episode of ventilator-acquired pneumonia (VAP) with a CPIS score greater than 6. (CPIS is a score used to help diagnose pneumonia in patients on ventilators.)
Patients who have been treated with antibiotics for less than 24 hours.
Patients with a monocyte HLA-DR level of less than 8000 AB/C. (HLA-DR is a marker on certain immune cells, and its level can indicate how well the immune system is functioning.)
A written informed consent must be signed by a trusted support person. (This means someone you trust agrees to the study on your behalf.)
Patients must be affiliated with a social security scheme.

Who cannot join the trial?

10 criteria

Patients who have a known allergy or severe reaction to **recombinant human interferon gamma** or any of its components cannot participate. **Recombinant human interferon gamma** is a type of protein used in the study.
Patients who are currently participating in another clinical trial or have participated in one within the last 30 days are not eligible.
Patients with a history of severe heart disease or heart failure are excluded. **Heart failure** means the heart is not pumping blood as well as it should.
Patients with severe liver disease cannot take part. **Liver disease** affects how the liver functions, which is important for processing medications.
Patients with severe kidney disease are not eligible. **Kidney disease** affects how the kidneys filter waste from the blood.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of certain types of cancer, except for skin cancer that is not melanoma, are excluded. **Melanoma** is a serious type of skin cancer.
Patients with a compromised immune system, which means their body's defense against infections is weakened, are not eligible.
Patients who have had an organ transplant are excluded.
Patients with a history of drug or alcohol abuse within the past year cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Verified
CHU Croix Rousse-Lyon
Lyon, France
Responsive
Hospices Civils De Lyon
Lyon, France

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Investigated drugs

Recombinant Human Interferon Gamma is a medication used in this clinical trial to help treat ventilator-acquired pneumonia in patients who are in the intensive care unit. This medication is a man-made version of a protein that your body naturally produces to help fight infections. In this study, it is being tested to see if it can help reduce the time patients need to be on a ventilator when they have pneumonia, in addition to the usual antibiotic treatment. The goal is to see if this medication can help improve the immune response in patients who have a specific immune marker level, making it easier for them to recover from pneumonia.

What is already known about the treatment

Human recombinant interferon gamma – This medication is administered through injection and is currently being studied for its effectiveness in treating ventilator-acquired pneumonia in patients in intensive care units. It is not yet widely used in medicine, as it is still under investigation in clinical trials. The main therapeutic use being explored is to help reduce the time patients need mechanical ventilation when they have this type of pneumonia. At the molecular level, it works by enhancing the immune system's ability to fight infections. It is classified as an immunomodulatory agent, which means it helps regulate the immune system.

Investigated diseases

Ventilator-associated pneumonia – Ventilator-associated pneumonia is a lung infection that occurs in people who are on mechanical ventilation breathing machines in hospitals. It typically develops 48 hours or more after intubation. The disease progresses as bacteria or other pathogens enter the lungs through the breathing tube, leading to inflammation and infection. Symptoms may include fever, increased white blood cell count, purulent sputum, and decreased oxygenation. As the infection progresses, it can cause lung tissue damage and impair respiratory function. The condition requires careful monitoring and management to prevent further complications.