Actively Recruiting
Biomarker-Guided Early Clarithromycin Treatment to Prevent Sepsis Progression in Community-Acquired Pneumonia
Led by Hellenic Institute for the Study of Sepsis · Updated on 2025-12-16
330
Participants Needed
24
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of early adjunctive clarithromycin treatment guided by the biomarker suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia (CAP) at risk. This phase 3 randomized clinical trial aims to optimize the clinical benefit shown in a previous trial and to provide evidence that early clarithromycin can improve immune response and prevent severe outcomes in CAP patients. The study is motivated by the need for early intervention before severe sepsis develops, using suPAR levels as an early warning tool. Participants will be randomly assigned to receive either oral clarithromycin 500 mg twice daily for seven days plus standard-of-care antibiotics or a placebo tablet twice daily plus standard-of-care antibiotics. The standard antibiotics follow current guidelines and may be adjusted by the doctor based on individual factors. The study includes a quadruple-blind design to compare these two groups and will be conducted in Greece. Treatment duration for both arms is seven days. During the study, participants will have assessments at multiple time points including respiratory symptom scores, organ failure scores (SOFA), and blood tests for inflammatory markers such as procalcitonin and interleukins. The main outcomes will be measured at day 4, with additional follow-up visits at 8, 14, 28, and 90 days to monitor pneumonia resolution, antibiotic use, survival, and mortality. Safety and immune response will also be tracked throughout the study to evaluate the effects of clarithromycin on CAP and sepsis progression.
CONDITIONS
Brief Title
Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age equal to or above 18 years
- Male or female gender
- Women of reproductive age must be willing to use dual contraceptive methods during the study
- Written informed consent provided by the patient or legally designated representative
- Diagnosis of community-acquired pneumonia (CAP)
- Presence of at least two of the following signs: cough, purulent sputum expectoration, dyspnea, or pleuritic chest pain
- Procalcitonin (PCT) level of 0.25 ng/ml or higher
- suPAR level of 6 ng/ml or higher
You will not qualify if you...
- Age below 18 years
- Denial of written informed consent
- Any stage IV malignancy
- Do not resuscitate decision in place
- Need for non-invasive or mechanical ventilation
- Hospitalization in Intensive Care Unit
- Infection by SARS-CoV-2
- Use of oral or IV corticosteroids at doses of 0.4 mg/kg prednisone or more for over 15 days
- Use of any macrolide antibiotics for the current CAP episode
- Known HIV infection
- Chronic anti-cytokine treatment for more than two months
- QTc interval at rest of 500 msec or more, or history of long QT syndrome
- Allergy to macrolides
- Concurrent use of certain medications unless stopped during the trial (e.g., astemizole, terfenadine, simvastatin)
- History of torsades de pointes arrhythmia
- End-stage liver or kidney failure
- Severe low potassium or magnesium unless corrected
- Contraindications for macrolide use
- Pregnancy or lactation
- Participation in another interventional trial within the last 30 days
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive oral clarithromycin 500 mg twice daily or placebo tablets for seven days, alongside standard antibiotics for community-acquired pneumonia as per guidelines.
Daily visits or assessments during treatment period
Duration - Up to 90 days
Participants are monitored for resolution of pneumonia, need for antibiotic escalation, survival, and other health outcomes up to 90 days after treatment.
Follow-up visits at approximately 14, 28, and 90 days
Trial Site Locations
Total: 24 locations
1
5th Pulmonary Department, SOTIRIA Athens General Hospital of Chest Diseases
Athens, Athens, Greece, 115 27
Actively Recruiting
2
1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming"
Athens, Greece, Greece
Not Yet Recruiting
3
1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
Athens, Greece, Greece
Actively Recruiting
4
1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital
Athens, Greece, Greece
Actively Recruiting
5
1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital
Athens, Greece, Greece
Actively Recruiting
6
1st Department of Internal Medicine, General University Hospital of Ioannina
Athens, Greece, Greece
Actively Recruiting
7
1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital
Athens, Greece, Greece
Actively Recruiting
8
1st Department of Internal Medicine, THRIASIO General Hospital of Elefsis
Athens, Greece, Greece
Actively Recruiting
9
1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens
Athens, Greece, Greece
Actively Recruiting
10
2nd Department of Internal Medicine, Attikon University Hospital
Athens, Greece, Greece
Actively Recruiting
11
2nd Department of Internal Medicine, THRIASIO General Hospital of Elefsis
Athens, Greece, Greece
Actively Recruiting
12
2nd Department of Internal Medicine, TZANEIO Piraeus General Hospital
Athens, Greece, Greece
Actively Recruiting
13
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Athens, Greece, Greece
Actively Recruiting
14
3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital
Athens, Greece, Greece
Actively Recruiting
15
3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO- BENAKEIO E.E.S.
Athens, Greece, Greece
Actively Recruiting
16
3rd University Department of Internal Medicine, SOTIRIA Athens General Hospital of Chest Diseases
Athens, Greece, Greece
Actively Recruiting
17
4th Department of Internal Medicine, Attikon University Hospital
Athens, Greece, Greece
Actively Recruiting
18
6th Pulmonary Medicine Department, SOTIRIA General Hospital of Chest Diseases of Athens
Athens, Greece, Greece
Actively Recruiting
19
Department of Chest Medicine, EVANGELISMOS Athens General Hospital
Athens, Greece, Greece
Actively Recruiting
20
Department of Internal Medicine, Larissa University General Hospital
Athens, Greece, Greece
Actively Recruiting
21
Department of Internal Medicine, Patras University General Hospital
Athens, Greece, Greece
Actively Recruiting
22
Department of Pulmonary Medicine, General Hospital of Kerkira
Athens, Greece, Greece
Actively Recruiting
23
Emergency Department, TZANEIO Piraeus General Hospital
Athens, Greece, Greece
Actively Recruiting
24
3rd Department of Internal Medicine, PAPAGEORGIOU General Hospital of Thessaloniki
Thessaloniki, Thessaloniki, Greece, 564 29
Actively Recruiting
Research Team
E
Evangelos J Giamarellos-Bourboulis, MD, Phd
A
Athanasia Chatzianastasiou, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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