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Using clarithromycin to prevent sepsis in pneumonia patients

Biomarker-Guided Early Elarithromycin Treatment to Prevent Sepsis Progression in Community-Acquired Pneumonia: The React Randomized Clinical Trial

PHASE3 · Hellenic Institute for the Study of Sepsis · NCT06294600

This study is testing if adding clarithromycin to the treatment of pneumonia can help prevent sepsis in patients who are at risk.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment330 (estimated)
Ages18 Years and up
SexAll
SponsorHellenic Institute for the Study of Sepsis (other)
Drugs / interventionsprednisone
Locations24 sites (Athens, Athens and 23 other locations)
Trial IDNCT06294600 on ClinicalTrials.gov

What this trial studies

The REACT clinical trial aims to evaluate the effectiveness of adjunctive clarithromycin treatment in patients with community-acquired pneumonia (CAP) who are at risk of progressing to sepsis. This phase 3 trial will randomize participants to receive clarithromycin guided by specific biomarkers, such as suPAR and PCT, to optimize treatment timing and improve immune response. The study will assess clinical outcomes and the resolution of pneumonia symptoms at follow-up visits. By intervening early, the trial seeks to reduce the risk of sepsis and improve patient survival rates.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with community-acquired pneumonia and exhibiting specific clinical signs and biomarker levels.

Not a fit: Patients with severe comorbidities, such as stage IV malignancy or those requiring intensive care, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly lower the risk of sepsis progression in patients with community-acquired pneumonia.

How similar studies have performed: Previous studies have shown promise in using adjunctive antibiotics for sepsis prevention, but this specific approach with clarithromycin is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age equal to or above 18 years
* Male or female gender
* In case of women of reproductive age, willingness to use dual contraceptive method during the study period
* Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation
* Community-acquired pneumonia (CAP)
* Presence of at least two of the following signs: i) cough; ii) purulent sputum expectoration; iii) dyspnea; and/or iv) pleuritic chest pain
* PCT ≥0.25 ng/ml
* suPAR ≥6 ng/ml

Exclusion Criteria:

* Age below 18 years
* Denial of written informed consent
* Any stage IV malignancy
* Any do not resuscitate decision
* Patients necessitating non-invasive ventilation or mechanical ventilation
* Hospitalization in Intensive Care Unit
* Infection by SARS-CoV-2
* Oral or IV intake of corticosteroids at a daily dose equal to or greater than 0.4 mg/kg prednisone for a period greater than the last 15 days
* Intake of any macrolide for the current episode of CAP under study
* Known infection by the human immunodeficiency virus
* Any chronic anti-cytokine treatment for more than two months
* QTc interval at rest in the ECG ≥500 msec or history of know long QT syndrome
* Medical history of allergy to macrolides
* Concomitant oral intake of astemizole, cizapride, doperidone, pimozide, terfenadine, midazolam, ranolazine, ergot alkaloids (e.g. ergotamine and dihydroergotamine), lomitapide and colchicine; patients may be enrolled in the trial if they stop these drugs during trial participation.
* Medical history of torsades de pointes arrhythmia
* Concomitant intake of lovostatin or simvastatin; patients may be enrolled in the trial if they stop these drugs during trial participation.
* Concomitant presence of end-stage liver failure and end-stage renal failure.
* Severe hypokalemia or severe hypomagnesemia; a patient may be enrolled one any of these electrolyte disturbances are restored.
* Any contradictions for macrolide uptake
* Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
* Participation in any other interventional trial within the last 30 days

Where this trial is running

Athens, Athens and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Community-acquired Pneumonia, CAP, CLARITHROMYCIN, SEPSIS, suPAR, PCT, ACCESS, SOFA

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.