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โ† Trials
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Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)

RecruitingPhase 3Ages 18 Years - anyAllHellenic Institute for the Study of Sepsis
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ0.25 ng/ml * suPAR โ‰ฅ6 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 โ‰ฅ500 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
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What it tests

  • Clarithromycin 500mg
  • Tablets
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Where

24 sites
5th Pulmonary Department, SOTIRIA Athens General Hospital of Chest Diseases
Athens, Greece
1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming"
Athens, Greece
1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
Athens, Greece
1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital
Athens, Greece
1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital
Athens, Greece
1st Department of Internal Medicine, General University Hospital of Ioannina
Athens, Greece
1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital
Athens, Greece
1st Department of Internal Medicine, THRIASIO General Hospital of Elefsis
Athens, Greece

โ€ฆand 16 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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