Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Dexamethasone and Sodium Chloride for Treating Severe Hospital-Acquired Pneumonia in Critically Ill Patients with a Proinflammatory Profile

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 hospital-acquired pneumonia, a type of lung infection that patients can get while staying in the hospital. The study is investigating the use of a medication called dexamethasone phosphate, which is given as a solution through an injection or infusion into the veins. This medication is being tested to see if it can help treat severe cases of hospital-acquired pneumonia in patients who have a strong inflammatory response, which means their bodies are reacting with a lot of inflammation.

The purpose of the study is to find out how effective dexamethasone phosphate is when used alongside the usual care that patients receive, compared to a placebo, which is a substance with no active medication. The study will involve patients receiving either the medication or the placebo, and their progress will be monitored over a period of time. The treatment with the medication or placebo will last for up to five days, and the patients' health will be checked regularly to see how they are responding to the treatment.

Throughout the study, researchers will look at various outcomes, such as whether the pneumonia is cured and the overall survival of the patients after 28 days. They will also monitor for any side effects or complications that might occur during the treatment period. The study aims to provide valuable information on whether dexamethasone phosphate can be a beneficial addition to the standard care for patients with severe hospital-acquired pneumonia.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed through informed consent from a legal representative or an emergency procedure, if necessary. Consent from the patient is obtained as soon as possible if they are unable to provide it initially.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of hospital-acquired pneumonia and ensuring the patient meets the inclusion criteria, such as age and specific health conditions.

  3. Step 3

    Randomization

    Participants are randomly assigned to receive either dexamethasone plus standard care or a placebo plus standard care. This process is double-blind, meaning neither the patient nor the healthcare providers know which treatment is being administered.

  4. Step 4

    Treatment administration

    The treatment involves the administration of dexamethasone phosphate and sodium chloride through intravenous use. The specific dosage and frequency are determined by the healthcare team based on the study protocol.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the patient's response to treatment. This includes daily evaluations of body temperature, heart rate, oxygen levels, and other vital signs. Blood tests are performed every 48 hours for 10 days to monitor leukocyte counts.

    The patient's progress is evaluated at specific intervals, including a test-of-cure visit and assessments at Day 28, Month 3, and Month 6.

  6. Step 6

    End of study participation

    Participation in the study concludes after the final assessment at Month 6. The study aims to determine the effectiveness of the treatment in achieving a clinical cure and reducing mortality rates.

Who can join the trial?

8 criteria

  • Adults aged between 18 and 85 years old.
  • Diagnosed with **hospital-acquired pneumonia**. This is a lung infection that occurs 48 hours or more after being admitted to the hospital. The diagnosis is based on certain signs like high body temperature, changes in white blood cell count, and lung changes seen on a chest X-ray.
  • Severe condition defined by a specific measure of lung function called **PaO2/FiO2 ratio** being less than 200 while on a breathing machine.
  • Showing signs of a strong body reaction to infection, with a **CRP** (a blood test that shows inflammation) level of 150 mg/L or higher.
  • Currently receiving treatment with antibiotics for the pneumonia for less than 48 hours.
  • Consent given by a legal representative or through an emergency procedure if the patient cannot consent themselves. If the patient is unable to consent at the start, their consent will be obtained as soon as possible.
  • Covered by a health insurance plan.
  • Women who can have children must agree to use effective birth control methods for the first 28 days of the study. This can include not having sex, using condoms with spermicide, contraceptive sponges, diaphragms, hormonal birth control, or intrauterine devices.

Who cannot join the trial?

5 criteria

  • Patients who do not have severe hospital-acquired pneumonia cannot participate. This is a type of lung infection that occurs in people who are in the hospital.
  • Patients who do not have a pro-inflammatory profile are excluded. This means their body is not showing signs of inflammation, which is the body's response to infection or injury.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups are excluded. This means the study is looking for specific types of patients.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or the elderly.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Dexamethasone is a medication used in this trial to treat severe hospital-acquired pneumonia in critically ill patients. It is a type of steroid that helps reduce inflammation in the body. In this study, it is being tested to see if it can improve outcomes for patients with a pro-inflammatory profile when added to the standard care they are already receiving.

What is already known about the treatment

Dexamethasone – Dexamethasone is administered orally or intravenously, depending on the severity of the condition being treated. It is currently being studied in clinical trials for its effectiveness in treating severe hospital-acquired pneumonia, particularly in patients with a pro-inflammatory profile. This medication is primarily used for its anti-inflammatory and immunosuppressant properties. At the molecular level, dexamethasone works by binding to glucocorticoid receptors, which then modulate the expression of anti-inflammatory proteins and suppress the expression of pro-inflammatory proteins. It is classified as a corticosteroid, a type of steroid hormone used to reduce inflammation and suppress the immune system.

Investigated diseases

Hospital-acquired pneumonia – This is a type of lung infection that occurs in patients during their stay in a hospital, typically 48 hours or more after admission. It is not present at the time of admission and is often caused by bacteria that are resistant to antibiotics. The disease progresses as bacteria invade the lungs, leading to inflammation and fluid accumulation in the air sacs. Patients may experience symptoms such as cough, fever, chills, and difficulty breathing. The condition can worsen if not managed properly, potentially leading to complications like respiratory failure. Hospital-acquired pneumonia is a significant concern due to its association with prolonged hospital stays and increased healthcare costs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508153-12-00Protocol codeRC23_0358Estimated enrolment476 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.