BENEFIT OF CLARITHROMYCIN IN PATIENTS WITH SEVERE INFECTIONS THROUGH MODULATION OF THE IMMUNE SYSTEM

Phase 1

• Conditions: IMMUNE MODULATION WITH CLARITHROMYCIN IN SEPSIS WITH MULTIPLE ORGAN AND RESPIRATORY DYSFUNCTION; MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-001056-55-GR
• Lead Sponsor: HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-07
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1.Adult patients (=18 years)
2.Patients of both genders
3.Informed consent form signed by patient or by first-degree relative in case of patient unable to consent
4.Negative (blood or urinary) pregnancy test for female patients of reproductive age
5.Willingness to receive contraception during and seven days after the administration of the study drug.
6.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. Definitions for these infections are given below.
7.Presence of sepsis as defined by the Sepsis-3 classification criteria3
8.Respiratory dysfunction defined as one PaO2/FiO2 ratio below 200
9.Total SOFA points for organ dysfunctions other than the respiratory function more than 3.

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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110

Exclusion Criteria

1.Denial for informed consent
2.Age inferior to 18 years
3.Pregnancy (confirmed by blood or urinary pregnancy test) or lactation for female patients of reproductive age.
4.Unwillingness to receive contraception during and seven days after the administration of the study drug.
5.HIV infection (with known CD4 cell count = 200/mm3)
6.Solid organ, or bone marrow transplantation
7.Corticosteroid oral or intravenous intake greater than 0.4 mg/kg of equivalent prednisone daily over the last 15 days
8.Known active neoplasms compromising short-term survival (1 month)
9.Neutropenia <1000/mm3
10.Known allergy to macrolides
11.Previous participation in the study
12.Administration of a macrolide for the current infection

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The study is aiming to assess the efficacy of intravenous treatment of clarithromycin in the reduction of 28-day mortality among patients with sepsis and respiratory dysfunction. ;Secondary Objective: Secondary aims are the effect on 90-day mortality, sepsis resolution and recurrence, mortality in the subgroup of patients with septic shock and finally, impact on biomarkers of sepsis-induced immunosuppression;Primary end point(s): To assess the impact of intravenously administered clartithromycin as adjunctive treatment to standard antibiotic therapy compared to placebo on all-cause 28-day mortality.;Timepoint(s) of evaluation of this end point: 28 days