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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Athens Naval Hospital Athens Greece
General Hospital Of Eleusina Thriasio Eleusina Greece
General Hospital Of Corfu Agia Eirini Corfu Greece
Evangelismos S.A. Athens Greece
General University Hospital Of Larissa Larissa Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
University General Hospital Of Ioannina Ioannina Greece
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
General University Hospital Of Patras Patras Greece
General Hospital Of Athens Korgialenio Benakio H.R.C. Athens Greece
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Geniko Nosokomeio Peiraia Tzaneio Piraeus Greece
General Hospital of Nikaia-Piraeus, “Agios Panteleimon” Piraeus Greece
Ssnlmdivamnu Gixlfwj Hpmvferp Athens Greece
Gtiyhxv Hjckjpsm oh Stkfw Syros Greece
Lawbx Gpaymmu Hbngtmmx Om Aoxiwx Athens Greece
Uzyegntamy Gnmidcx Hslbjxzb Alunwsj Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Recruiting
15.11.2023

Trial locations

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.

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 ID:
2023-507295-40-00
Protocol code:
REACT
Trial Phase:
Therapeutic confirmatory (Phase III)

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