Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)

Launched by HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS · Feb 28, 2024

Keywords

ClinConnect Summary

The REACT trial is studying whether an antibiotic called clarithromycin can help prevent severe illness, known as sepsis, in patients with community-acquired pneumonia (CAP). This trial aims to find out if starting clarithromycin early, based on certain blood test results, can improve patients' recovery and help their immune systems fight the infection more effectively. Researchers are particularly interested in how this treatment can improve symptoms and overall health during the recovery process.

To participate in the trial, you must be at least 18 years old and have community-acquired pneumonia, which means you got the infection outside of a healthcare setting. You should also show at least two specific symptoms, like a cough or difficulty breathing, and meet certain blood test criteria. Participants will receive clarithromycin and will be monitored throughout the study to see how well they respond to the treatment. It's important to note that there are some health conditions that would exclude you from participating, such as severe heart problems or being pregnant. If you think you might be eligible and are interested in helping advance medical knowledge, this trial could be an opportunity for you.

Gender

ALL

Eligibility 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