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Study on Early Clarithromycin Treatment to Prevent Sepsis in Patients with Community-Acquired Pneumonia

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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 community-acquired pneumonia, a type of lung infection that is acquired outside of a hospital setting. The trial will use a medication called Clarithromycin, which is a type of antibiotic that helps fight bacterial infections. The purpose of the study is to determine if early treatment with Clarithromycin, guided by specific biomarkers, can prevent the progression of pneumonia into a more severe condition known as sepsis.

Participants in the study will be randomly assigned to receive either Clarithromycin or a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of up to seven days, during which participants will take the medication orally in the form of film-coated tablets. The trial aims to optimize the benefits of Clarithromycin treatment and provide evidence for its effectiveness in preventing sepsis in patients at risk.

Throughout the study, participants will be monitored for changes in their symptoms and overall health. The trial will assess whether the treatment helps reduce symptoms such as cough, difficulty breathing, and chest pain, and whether it prevents the development of new organ dysfunctions. The study will also evaluate the need for additional antibiotics and the overall recovery of participants, including their discharge from the hospital. The findings from this trial could provide valuable insights into the management of community-acquired pneumonia and its complications.

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, eligibility is confirmed based on specific criteria such as age, gender, and health condition. Written informed consent is required.

    Participants must have community-acquired pneumonia and meet certain health markers.

  2. Step 2

    Initial assessment

    An initial health assessment is conducted to establish baseline health markers. This includes measuring symptoms like cough, sputum production, and chest pain.

    Blood tests are performed to measure specific proteins and markers in the blood.

  3. Step 3

    Medication administration

    Participants receive either clarithromycin or a placebo. Clarithromycin is administered as a 500 mg film-coated tablet taken orally.

    The medication is taken as prescribed by the study protocol, which is typically once daily.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored regularly to assess the effectiveness of the treatment. This includes checking for symptom improvement and any side effects.

    Blood tests are repeated to track changes in health markers.

  5. Step 5

    Evaluation of primary endpoint

    On day 4, the primary endpoint is evaluated. Success is defined by a reduction in symptoms and specific blood markers.

    Participants must meet all conditions to be considered successful in reaching the primary endpoint.

  6. Step 6

    Secondary outcomes assessment

    Secondary outcomes are assessed up to day 28. These include the development of new organ dysfunctions, progression into sepsis, and overall clinical success.

    Additional assessments may include changes in immune response and hospital discharge status.

  7. Step 7

    End of treatment evaluation

    At the end of the treatment period, a final evaluation is conducted to assess overall health improvement and any long-term effects.

    The study aims to determine the effectiveness of early clarithromycin treatment in preventing sepsis progression.

Who can join the trial?

11 criteria

  • Must be **18 years old or older**
  • Can be **male or female**
  • If a woman is of childbearing age, she must be willing to use **two forms of birth control** during the study
  • Must provide **written informed consent**. If unable to make decisions, consent must be given by a legally authorized representative
  • Must have at least two of the following symptoms:
    • **Cough**
    • **Coughing up thick mucus**
    • **Shortness of breath** (also known as dyspnea)
    • **Chest pain when breathing or coughing** (known as pleuritic chest pain)
    • Must have **community-acquired pneumonia (CAP)**
    • Must have a **PCT level of 0.25 ng/ml or higher**. PCT is a substance in the blood that can indicate infection
    • Must have a **suPAR level of 6 ng/ml or higher**. suPAR is a protein in the blood that can indicate inflammation or infection risk

Who cannot join the trial?

4 criteria

  • Patients who are not at risk of developing sepsis from community-acquired pneumonia cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who do not meet the gender criteria for the study cannot participate.
  • Patients who are part of a vulnerable population that is not selected for the study cannot participate.
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Investigated drugs

Clarithromycin is an antibiotic used in this trial to help prevent the progression of community-acquired pneumonia into sepsis. The study aims to determine if starting clarithromycin early, guided by specific biomarkers, can provide clinical benefits for patients at risk.

What is already known about the treatment

Clarithromycin – Clarithromycin is administered orally, typically in tablet or liquid form. It is currently being studied in clinical trials for its potential to prevent the progression of community-acquired pneumonia into sepsis. The main therapeutic use of clarithromycin is to treat various bacterial infections, including respiratory tract infections. At the molecular level, clarithromycin works by inhibiting bacterial protein synthesis, effectively stopping the growth of bacteria. It is classified as a macrolide antibiotic.

Investigated diseases

Community-acquired pneumonia – This is an infection of the lungs that occurs in individuals who have not recently been hospitalized. It is typically caused by bacteria, viruses, or fungi that are inhaled into the lungs. The disease often begins with symptoms such as cough, fever, and difficulty breathing. As it progresses, patients may experience chest pain, increased sputum production, and fatigue. In severe cases, it can lead to complications like fluid accumulation in the lungs or difficulty in oxygen exchange. The progression and severity can vary based on the individual's overall health and the specific pathogen involved.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507295-40-00Protocol codeREACTEstimated enrolment330 patientsSponsorHellenic Institute For The Study Of Sepsis

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