Biomarker-Guided Early Clarithromycin Treatment To Prevent Sepsis Progression In Community-Acquired Pneumonia: The REACT Randomized Clinical Trial

Phase 1

• Conditions: Community-acquired pneumonia; MedDRA version: 20.0Level: PTClassification code: 10040047Term: Sepsis Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-507295-40-00
• Lead Sponsor: Hellenic Institute For The Study Of Sepsis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-05
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

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, Presence of at least two of the following signs: i) cough; ii) purulent sputum expectoration; iii) dyspnea; and/or iv) pleuritic chest pain, Community-acquired pneumonia (CAP), PCT =0.25 ng/ml, suPAR =6 ng/ml

Exclusion Criteria

Age below 18 years, 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, Denial of written informed consent, 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, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified