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Study of Baricitinib for Treating Hospital-Acquired Pneumonia in Critically Ill Patients with a Proinflammatory Profile

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 the treatment of hospital-acquired pneumonia in patients who are critically ill and have a specific type of inflammation in their bodies. The treatment being tested is a medication called baricitinib, which is available in the form of film-coated tablets known as Olumiant. The study will compare the effects of baricitinib combined with the usual care provided in hospitals to the usual care alone.

The purpose of the study is to determine if adding baricitinib to the standard treatment is safe and effective for patients with hospital-acquired pneumonia. Participants in the study will receive either baricitinib or a placebo, along with the standard care they would normally receive. The study will take place over a period of time, and participants will be monitored to see how well they respond to the treatment and to check for any side effects.

Throughout the study, researchers will look at various outcomes, such as whether the treatment helps cure the pneumonia and if it affects the overall health and quality of life of the patients. The study will also assess the economic impact of using baricitinib in treating pneumonia. The results will help determine if baricitinib can be a beneficial addition to the treatment of hospital-acquired pneumonia in critically ill patients.

The research process

The trial runs in 7 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, you will be informed about the trial's purpose and procedures. Consent will be obtained from your legal representative if you are unable to provide it yourself. If you are in a condition where you cannot consent, it will be obtained as soon as possible.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes checking if you have hospital-acquired pneumonia and are receiving antimicrobial therapy for less than 72 hours. Your age should be between 18 and 85 years.

  3. Step 3

    Randomization

    You will be randomly assigned to one of two groups. One group will receive baricitinib plus standard care, and the other will receive standard care alone. This process ensures that the study results are unbiased.

  4. Step 4

    Medication administration

    If you are in the group receiving baricitinib, you will take either 2 mg or 4 mg film-coated tablets. These are taken orally, once daily, as part of your treatment for hospital-acquired pneumonia.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored. This includes regular check-ups to assess the effectiveness and safety of the treatment. You will be observed for any side effects or unexpected reactions.

  6. Step 6

    Test-of-cure visit

    A visit will be scheduled to determine if the treatment has been successful. This is known as the test-of-cure visit, where your recovery from pneumonia will be evaluated.

  7. Step 7

    Final assessment

    At the end of the study period, a final assessment will be conducted. This includes evaluating your overall health and any changes in your quality of life. The study aims to determine the safety and effectiveness of baricitinib in treating hospital-acquired pneumonia.

Who can join the trial?

6 criteria

  • Adult patients aged between 18 and 85 years old.
  • Patients with ventilator-associated pneumonia (VAP) or hospital-acquired pneumonia that requires a breathing machine.
  • Patients showing a biological systemic inflammatory response, which means their body is reacting with inflammation, as defined by the hospital's standard care.
  • Patients who have been receiving antimicrobial therapy (medication to fight infections) for their current pneumonia episode for less than 72 hours.
  • Consent must be obtained from a legal representative, or through an emergency procedure if possible. If the patient is unable to give consent (for example, if they are unconscious), consent for continuing the study will be obtained as soon as possible.
  • The patient must be insured under a health insurance scheme.

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing hospital-acquired pneumonia. This is a type of lung infection that occurs during a hospital stay.
  • Patients who do not have a pro-inflammatory profile. This means their body is not showing signs of increased inflammation, which is a response to infection or injury.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups. The study is designed for specific groups of patients.
  • Patients who are not considered part of a vulnerable population. This refers to groups of people who might be at higher risk of harm or exploitation.
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Investigated drugs

Baricitinib is a medication that is being tested in this clinical trial to see if it can help treat hospital-acquired pneumonia in patients who are very sick and have a lot of inflammation in their bodies. This medication works by reducing inflammation, which is the body's response to infection or injury. In this study, baricitinib is given to patients along with the usual care they would receive in the hospital. The goal is to find out if adding baricitinib to the standard treatment can make patients get better faster or improve their overall health outcomes.

What is already known about the treatment

Baricitinib – Baricitinib is administered orally in the form of a tablet. It is currently being studied in clinical trials for its potential use in treating hospital-acquired pneumonia, particularly in critically ill patients with a pro-inflammatory profile. The main therapeutic indication being explored is its ability to reduce inflammation and improve outcomes in these patients. At the molecular level, baricitinib works by inhibiting certain enzymes called Janus kinases (JAKs), which play a role in the inflammatory process. It is classified pharmacologically as a JAK inhibitor.

Investigated diseases

Hospital-acquired pneumonia – Hospital-acquired pneumonia is a lung infection that occurs in patients during their stay in a hospital, typically 48 hours or more after admission. It is caused by bacteria, viruses, or fungi that are different from those causing community-acquired pneumonia. The disease progresses as the pathogens 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, leading to further respiratory complications. It is more common in patients with weakened immune systems or those using ventilators.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-503480-42-00Protocol codeRC22_0522Estimated enrolment450 patientsSponsorCentre Hospitalier Universitaire De Nantes

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