RecruitingOBSERVATIONAL

LUNG INFECTION in ICU (LUNG-I3)

This study, called LUNG-I3, is investigating lung infections, specifically a serious type of pneumonia called Ventilator-Associated Pneumonia (VAP), which can affect patients on breathing machines in intensive care. The main goal is to understand the differences in immune cells found in both the blood and a special sample taken from the lungs (called a bronchoalveolar lavage, or BAL) after an infection. Researchers are particularly interested in two types of immune cells: alveolar macrophages and neutrophils. By looking closely at how these cells work and what they contain, the study hopes to gain new insights into how the body responds to these severe infections. Understanding these cellular differences could help improve future treatments and care for critically ill patients with lung infections.

At a glance

Status

Recruiting

Sponsor

BioMérieux

Enrolment target

Start

05 Dec 2023

Estimated completion

01 Jun 2027

VAP - Ventilator Associated Pneumonia

What is this study about?

Imagine your body as having its own army to fight off germs and infections. When you get a severe lung infection, like pneumonia, especially if you're in intensive care and need help breathing with a machine, this army goes into action. This study, called LUNG-I3, is like a spy mission to find out exactly how different parts of that army are behaving.

The researchers want to look very closely at the tiny cells that are part of your immune system – the 'soldiers' that fight infection. They'll be comparing these cells from two places: your blood, and a special fluid taken from your lungs. This fluid is collected during a procedure called a bronchoalveolar lavage (BAL), where a small amount of saline solution is washed into your lungs and then collected back. The main focus is on two specific types of immune cells, called alveolar macrophages and neutrophils, to see how they change and what they're doing when there's an infection.

The reason this study matters is that serious lung infections in intensive care can be very dangerous. By understanding exactly how our immune system responds at a cellular level, doctors hope to find better ways to diagnose these infections earlier, treat them more effectively, and ultimately improve the chances of recovery for very unwell patients. It's about getting a clearer picture so we can develop better strategies to help people fight these illnesses.

Key takeaways

This study is about understanding severe lung infections in intensive care.
It focuses on how immune cells in blood and lung fluid respond to infection.
No new treatments are given; it's an observational study.
Participation helps scientists learn more for future patients.
You or your representative must give permission to take part.
You can always withdraw from the study without affecting your care.

Who may be eligible?

To join this study, you must be 18 years or older and currently a patient in intensive care. You would typically be suffering from a very serious condition such as severe blood poisoning (septic shock) caused by pneumonia or another infection, a major injury like severe trauma, or extensive burns covering a significant part of your body. You also need to meet certain medical criteria that show how unwell you are.

There are several reasons someone might not be able to join. For example, if your pneumonia was caused by inhaling something (like vomit), or if you have a long-term lung condition like COPD, or if you've recently had chemotherapy, an organ transplant, or are taking strong medication to suppress your immune system. Pregnant or breastfeeding women also cannot participate.

Crucially, you, or someone legally responsible for you, must be able to understand and give written permission to take part in the study. This ensures that everyone involved makes an informed choice. Certain legal situations, such as being under a legal protection order or not being affiliated with a health insurance scheme, would also prevent participation, particularly in France.

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 an intensive care patient with a severe condition like septic shock, major trauma, or extensive burns?
Do you, or someone representing you, understand and agree to give written permission?
Are you NOT pregnant or breastfeeding?
Are you NOT significantly immunosuppressed (e.g., due to recent chemotherapy, organ transplant, or strong immune-suppressing drugs, or certain medical conditions)?
Is your pneumonia NOT due to inhaling something (like vomit)?
Do you NOT have chronic obstructive pulmonary disease (COPD)?

Answer every question to see your result.

What does participation involve?

This study focuses on understanding your body's response to infection and typically involves collecting blood samples and a special fluid from your lungs (called a bronchoalveolar lavage, or BAL). A BAL is a common procedure in intensive care and involves a doctor gently washing a small amount of fluid into a part of your lung through a thin tube and then collecting it. This allows researchers to get cells directly from the infection site. These procedures are part of your routine medical care where possible, but additional samples might be taken for the study. There are no new medications or treatments given as part of this research, as it's an observational study designed to collect information. The duration of your participation would be limited to the time you are in intensive care, focusing on these initial sample collections. There are no long-term follow-up visits or additional appointments required beyond your standard hospital care.

Potential risks and benefits

The potential benefit of taking part in this study is that the information gathered from your samples could help future patients by leading to a better understanding of severe lung infections and potentially improved treatments. While there are no direct personal health benefits for you specifically, your contribution is valuable scientific research. The risks are typically associated with the standard medical procedures like blood draws and the bronchoalveolar lavage (BAL), which are already part of intensive care treatment and can carry a small risk of discomfort or complications, as with any medical procedure. However, the study aims to use samples collected during necessary clinical procedures whenever possible. You always have the right to withdraw from the study at any time, without it affecting your medical care.

Locations (1)

Hopital Edouard Herriot
Verified postcode
Lyon, France· Recruiting

Common questions

What is 'Ventilator-Associated Pneumonia' (VAP)?

VAP is a serious lung infection that can develop in patients who are on a breathing machine (ventilator) in intensive care.

What is a 'bronchoalveolar lavage' (BAL)?

A BAL is a procedure where a doctor washes a small amount of fluid into your lungs through a thin tube and then collects it to get samples of cells and fluid from inside your lungs.

Will I receive a new treatment in this study?

No, this study is about understanding infections better by looking at samples. You will not receive any new or experimental treatments as part of this research.

Can I leave the study if I change my mind?

Yes, you or your legal representative can decide to withdraw from the study at any time, and it will not affect your medical care.

What are 'immune cells' and why are they important?

Immune cells are special cells in your body that fight off infections and diseases. This study looks at them to understand how your body responds to severe lung infections.

How to find out more

Jean-François LLITJOS

jeanfrancois.llitjos@biomerieux.com +33761568397 Official trial record

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