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RECRUITING

NCT06294600

PHASE3

Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)

Sponsor: Hellenic Institute for the Study of Sepsis

View on ClinicalTrials.gov

Summary

The primary objective of the REACT randomized clinical trial (RCT) is to optimize the clinical benefit from adjunctive clarithromycin treatment shown in the ACCESS trial and to provide evidence for the clinical benefit of early start of adjunctive oral clarithromycin guided by suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia (CAP) at risk. This can be achieved by endpoints incorporating clinical benefit with the effect of treatment on the improvement of the immune dysregulation of CAP. The secondary objectives of REACT are to investigate the impact of early adjunctive treatment with clarithromycin on the resolution of CAP at the test-of-cure (TOC) visit.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2024-02-12

Completion Date

2026-07-30

Last Updated

2025-12-16

Healthy Volunteers

Conditions

Community-acquired Pneumonia

Interventions

DRUG

Clarithromycin 500mg

Oral tablets of 500mg of clarithromycin

DRUG

Tablets

Oral tablets of similar appearance to active study drug

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

Locations (24)

5th Pulmonary Department, SOTIRIA Athens General Hospital of Chest Diseases

Athens, Athens, Greece

1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming"

Athens, Greece, Greece

1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki

Athens, Greece, Greece

1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital

Athens, Greece, Greece

1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital

Athens, Greece, Greece

1st Department of Internal Medicine, General University Hospital of Ioannina

Athens, Greece, Greece

1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital

Athens, Greece, Greece

1st Department of Internal Medicine, THRIASIO General Hospital of Elefsis

Athens, Greece, Greece

1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens

Athens, Greece, Greece

2nd Department of Internal Medicine, Attikon University Hospital

Athens, Greece, Greece

2nd Department of Internal Medicine, THRIASIO General Hospital of Elefsis

Athens, Greece, Greece

2nd Department of Internal Medicine, TZANEIO Piraeus General Hospital

Athens, Greece, Greece

2nd Department of Internal Medicine, University General Hospital of Alexandroupolis

Athens, Greece, Greece

3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital

Athens, Greece, Greece

3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO- BENAKEIO E.E.S.

Athens, Greece, Greece

3rd University Department of Internal Medicine, SOTIRIA Athens General Hospital of Chest Diseases

Athens, Greece, Greece

4th Department of Internal Medicine, Attikon University Hospital

Athens, Greece, Greece

6th Pulmonary Medicine Department, SOTIRIA General Hospital of Chest Diseases of Athens

Athens, Greece, Greece

Department of Chest Medicine, EVANGELISMOS Athens General Hospital

Athens, Greece, Greece

Department of Internal Medicine, Larissa University General Hospital

Athens, Greece, Greece

Department of Internal Medicine, Patras University General Hospital

Athens, Greece, Greece

Department of Pulmonary Medicine, General Hospital of Kerkira

Athens, Greece, Greece

Emergency Department, TZANEIO Piraeus General Hospital

Athens, Greece, Greece

3rd Department of Internal Medicine, PAPAGEORGIOU General Hospital of Thessaloniki

Thessaloniki, Thessaloniki, Greece

Clinical Research Directory

Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (24)