ADMINISTRATION OF CLARITHROMYCIN IN COMMUNITY-ACQUIRED PNEUMONIA

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Attenuation of the high inflammatory burden in Community-Aquired Pneumonia (CAP); MedDRA version: 20.0Level: PTClassification code 10035664Term: PneumoniaSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2020-004452-15-GR
• Lead Sponsor: Hellenic Institute for the Study of Sepsis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-05
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

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