A RANDOMIZED CLINICAL TRIAL OF ORAL CLARITHROMYCIN IN COMMUNITY-ACQUIRED PNEUMONIA TO ATTENUATE INFLAMMATORY RESPONSES AND IMPROVE OUTCOMES (THE ACCESS TRIAL)

Hellenic Institute for the Study of Sepsis0 个研究点目标入组 278 人开始时间: 2020年11月5日最近更新: 2022年2月7日

适应症

试验速览

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•Age =18 years
•Male of female gender
•In case of non-menopausal women, unwillingness to become pregnant during the study period. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study.
•Written informed consent provided by the patients or by a first-degree relative in case of patients unable to consent
•Presence of at least two signs of SIRS
•SOFA score =2
•PCT =0.25 ng/ml
•Presence of at least two of the following signs: i) cough; ii) purulent sputum expectoration; iii) dyspnea; and/or iv) pleuritic chest pain
•Presence of CAP
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 93
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 185

•Age below 18 years
•Denial of written informed consent
•Intake of any macrolide for the current episode of CAP under study
•Oral or intravenous intake of corticosteroids defined as any more than 0.4mg/kg daily intake of equivalent prednisone for the last 15 days
•Neutropenia defined as an absolute neutrophil count below 1,000/mm3
•Known infection by the human immunodeficiency virus
•Any chronic anti-cytokine treatment (e.g. antibodies against TNF for rheumatoid arthritis)
•Infection by the SARS-CoV-2 virus
•Hospitalization for more than 2 days the last 90 days
•QTc interval at rest ECG =500 msec or history of known congenital long QT syndrome
•Concomitant administration with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4, (lovastatin or simvastatin), and presence of any contraindications for the study drugs
•Pregnancy or lactation

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