Status:
COMPLETED
Benefit of Clarithromycin in Patients With Severe Infections Through Modulation of the Immune System
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Collaborating Sponsors:
European Commission
Conditions:
Sepsis
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
High mortality associated with sepsis and Multiple Organ Dysfunction Syndrome (MODS) calls for alternative, individualized therapies in selected patients that might benefit form specific interventions...
Detailed Description
Sepsis is a condition with actually rising incidence, estimated around 19 cases per 1000 hospitalizations per year in academic hospitals in USA and similar trends in Europe. It is associated with unac...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years)
- Patients of both genders
- Informed consent form signed by patient or by first-degree relative in case of patient unable to consent
- Negative (blood or urinary) pregnancy test for female patients of reproductive age
- Willingness to receive contraception during and seven days after the administration of the study drug.
- Presence of one or more of the following infections: hospital-acquired pneumonia (HAP), health-care associated pneumonia (HCAP), ventilator-associated pneumonia (VAP), primary Gram-negative bacteremia and intra-abdominal infections.
- Presence of sepsis as defined by: Sequential Organ Failure Assessment (SOFA) score of 2 or more points for patients who are admitted with infection at the emergency department or increase of admission SOFA score by 2 or more points consequent to infection, for patients already hospitalized
- Respiratory dysfunction defined as one Partial Arterial Oxygen Pressure to Fraction of Inspired Oxygen (PaO2/FiO2) ratio inferior to 200, independently of the Positive End Expiratory Pressure (PEEP) level.
- Total SOFA points for organ dysfunctions other than the respiratory function more than 3
Exclusion
- Denial for informed consent
- Age inferior to 18 years
- Pregnancy (confirmed by blood or urinary pregnancy test) or lactation for female patients of reproductive age.
- Unwillingness to receive contraception during and seven days after the administration of the study drug.
- HIV infection (with known Cluster of Differentiation 4-positive \[CD4\] cell count ≤ 200/mm3)
- Solid organ, or bone marrow transplantation
- Corticosteroid oral or intravenous intake greater than 0.4 mg/kg of equivalent prednisone daily over the last 15 days
- Known active neoplasms compromising short-term survival (1 month)
- Neutropenia \<1000/mm3
- Known allergy to macrolides
- Previous participation in the study
- Administration of a macrolide for the current infection
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03345992
Start Date
December 15 2017
End Date
December 19 2020
Last Update
December 22 2020
Active Locations (12)
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1
Intensive Care Unit, Saint-Pierre University Hospital
Brussels, Belgium, 1000
2
Intensive Care Unit, Brugmann University Hospital
Brussels, Belgium, 1020
3
Intensive Care Unit, Erasme University Hospital
Brussels, Belgium, 1070
4
Intensive Care Unit, Korgialeneio-Benakeio General Hospital
Athens, Greece, 11526