Recruiting

Study on the Effects of Iloprost Trometamol in Patients with Infectious Lung Disease on Mechanical Ventilation

Verified siteRegistered drugNo placebo

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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 a condition known as infectious pulmonary endotheliopathy, which affects the blood vessels in the lungs and can lead to severe breathing problems. The trial will explore the effects of a treatment using a medication called Ilomedin, which contains the active substance iloprost trometamol. This medication is given as a solution for infusion, meaning it is administered directly into the bloodstream over a period of time. The study will compare the effects of Ilomedin to a placebo to see if it can help reduce the risk of death within 28 days for patients who are on mechanical ventilation due to this lung condition.

The purpose of the study is to determine if a continuous infusion of Ilomedin at a specific dose can improve survival rates in patients with infectious pulmonary endotheliopathy. Participants in the study will receive the treatment for 72 hours while being closely monitored. The trial will also look at other factors, such as the number of days patients can live without needing additional support like vasopressors, which are medications that help maintain blood pressure, or mechanical ventilation, which is a machine that helps with breathing.

This study is important because it aims to find a potential new treatment option for patients with severe lung infections who require intensive care. By understanding the effects of Ilomedin, researchers hope to improve outcomes for these patients and provide better care in the future. The trial is expected to continue until 2026, with the goal of gathering enough information to make informed conclusions about the treatment's effectiveness and safety.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria: being an adult patient in intensive care, having a suspected lung infection, requiring mechanical ventilation for less than 24 hours, and having a specific biomarker level in the blood.
Step 2
Treatment administration
The treatment involves a continuous infusion of iloprost at a dose of 1 nanogram per kilogram per minute. This infusion lasts for 72 hours.
The medication is administered as a solution for infusion, which means it is delivered directly into the bloodstream through an intravenous line.
Step 3
Monitoring and observation
During the treatment, the patient's health is closely monitored to observe any changes or reactions.
The focus is on assessing the impact of the treatment on survival rates over a 28-day period.
Step 4
Follow-up period
After the initial treatment phase, the patient's condition is evaluated over a longer period, up to 90 days.
This includes tracking survival rates, the need for additional medical support like vasopressors or mechanical ventilation, and any serious side effects.

Who can join the trial?

4 criteria

Must be an adult patient in intensive care, which means you are 18 years or older and receiving specialized medical treatment.
Must have a suspected lung infection.
Must require a machine to help you breathe, known as mechanical ventilation, and this should have started less than 24 hours before being considered for the study.
Must have a specific level of a substance in your blood called an endothelial biomarker (sTM), which should be 4 ng/mL or higher. This is a measure related to the cells lining your blood vessels.

Who cannot join the trial?

9 criteria

Patients with other serious infections that are not related to the lungs cannot participate.
Patients who have a history of severe allergic reactions to similar medications are excluded.
Pregnant or breastfeeding women are not allowed to join the study.
Individuals with severe liver or kidney problems are not eligible.
Patients who are currently participating in another clinical trial cannot take part.
People with certain heart conditions that could be worsened by the study medication are excluded.
Patients who have had a recent major surgery are not eligible.
Individuals with a history of drug or alcohol abuse may be excluded.
Patients who are unable to give informed consent, meaning they cannot fully understand and agree to the study, are not allowed to participate.

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Verified sites

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

Verified
Herlev Hospital
Herlev, Denmark
Verified
Hillerod Hospital
Hillerød, Denmark
Verified
Region Sjaelland
Holbæk, Denmark

Trial locations

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Investigated drugs

Iloprost is a medication used in this trial to help improve blood flow in the lungs. It is given as a continuous infusion over 72 hours to patients who are on mechanical ventilation due to severe lung infections. The goal is to see if it can reduce the risk of death within 28 days by improving lung function and reducing damage to the blood vessels in the lungs.

What is already known about the treatment

Iloprost – Iloprost is administered as a continuous infusion, typically through an intravenous line, over a period of 72 hours. It is currently being studied in clinical trials for its potential to reduce mortality in patients with infectious pulmonary endotheliopathy who are mechanically ventilated. The main therapeutic indication for iloprost in this context is to improve outcomes in severe lung conditions associated with infection. At the molecular level, iloprost works by mimicking the effects of prostacyclin, a natural compound in the body that dilates blood vessels and inhibits platelet aggregation, thereby improving blood flow and reducing inflammation. It is classified pharmacologically as a prostacyclin analog.

Investigated diseases

Infectious Pulmonary Endotheliopathy – This disease involves inflammation and damage to the inner lining of blood vessels in the lungs, often caused by an infection. It can lead to impaired blood flow and oxygen exchange in the lungs, resulting in respiratory difficulties. As the condition progresses, it may cause increased pressure in the pulmonary arteries and contribute to the development of pulmonary hypertension. The inflammation can also lead to fluid leakage into lung tissues, causing pulmonary edema. Over time, this can result in decreased lung function and increased strain on the heart. The disease requires careful monitoring to manage symptoms and prevent complications.