Status:
COMPLETED
Anti-inflammatory Action of Oral Clarithromycin in Community-acquired Pneumonia
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Conditions:
Community-acquired Pneumonia
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Traditional management of community-acquired pneumonia (CAP) relies on the prompt administration of antimicrobials that target the most common causative pathogens. Retrospective analysis of observatio...
Detailed Description
Community-acquired pneumonia (CAP) is one of the most common bacterial infections and a leading cause of death globally since many patients deteriorate into sepsis and organ dysfunction. Traditional m...
Eligibility Criteria
Inclusion
- Adult patients (≥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 (see below for definition)
- SOFA score ≥2 (see Appendix I)
- 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 (see below for definition)
- SIRS is defined by the presence of at least two of the following criteria:
- Core temperature \>38 Celsius degrees or \<36 Celsius degrees
- Heart rate \>90 beats/minute
- Breath rate \>20 breaths/minute or pco2\<32 mmHg
- Total white blood cell count \>12,000/mm3 or \<4,000/mm3 or \>15% bands
- CAP is defined as the presence of auscultatory findings compatible with CAP and new consolidation in chest X-ray in a patient without any history of contact with the hospital environment or with health-care facilities the last 90 days.
Exclusion
- Age below 18 years
- Denial of written informed consent
- Presence of infection by SARS-CoV-2 (COVID-19)
- 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)
- 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 drug
- Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2023
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT04724044
Start Date
January 25 2021
End Date
April 11 2023
Last Update
December 12 2023
Active Locations (18)
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1
4th Department of Internal Medicine, Attikon University Hospital
Athens, Greece, 12462
2
1st Department of Internal Medicine, Amalia Fleming General Hospital
Athens, Greece
3
1st Department of Internal Medicine, Gennimatas General Hospital
Athens, Greece
4
1st Department of Internal Medicine, Konstantopouleio-Patission General Hospital
Athens, Greece