Using clarithromycin to prevent sepsis in pneumonia patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 5th Pulmonary Department, SOTIRIA Athens General Hospital of Chest Diseases
  Athens, Athens, Greece Recruiting
• 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
  Athens, Greece, Greece Recruiting
• 1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital
  Athens, Greece, Greece Recruiting
• 1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital
  Athens, Greece, Greece Recruiting
• 1st Department of Internal Medicine, General University Hospital of Ioannina
  Athens, Greece, Greece Recruiting
• 1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital
  Athens, Greece, Greece Recruiting

Study contacts

• Study coordinator: Evangelos J Giamarellos-Bourboulis, MD, Phd
• Email: egiamarel@med.uoa.gr
• Phone: 2105831994

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.