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

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL STUDY OF THE EFFICACY OF INTRAVENOUS CLARITHROMYCIN AS ADJUNCTIVE TREATMENT IN PATIENTS WITH SEPSIS AND RESPIRATORY AND MULTIPLE ORGAN DYSFUNCTION SYNDROME: THE INCLASS STUDY - INTRAVENOUS CLARITHROMYCIN IN SEPSIS AND MULTIPLE ORGAN DYSFUNCTION SYNDROME

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001056-55-GR

Enrollment

110

Registered

2017-06-07

Start date

2017-08-28

Completion date

Unknown

Last updated

2017-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IMMUNE MODULATION WITH CLARITHROMYCIN IN SEPSIS WITH MULTIPLE ORGAN AND RESPIRATORY DYSFUNCTION MedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: KLARICID PD.SOL.INF 500MG/VIAL BTx1VIAL Pharmaceutical Form: Powder for solution for injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intrave

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): To assess the effect of clarithromycin treatment compared to placebo treatment on the following: • 28-day mortality in the subgroup of patients with septic shock • All-cause 90-day mortality • Early sepsis response, defined by an at least 25% decrease of day 1 SOFA score on day 3 • Sepsis resolution; this is defined by an at least 25% decrease of day 1 SOFA score on day 7 • New sepsis episode until day 28. A new sepsis episode is noted in any patient who experiences at least 25% decrease of day 1 SOFA score on day 7 and who has further increase of day 7 total SOFA by at least 2 points, consequent to infection • Time until new sepsis episode. A new sepsis episode is noted in any patient who experiences at least 25% decrease of day 1 SOFA score on day 7 and who has further increase of day 7 total SOFA by at least 2 points, consequent to infection • Biomarkers of sepsis-induced immunosuppression through transcriptome, metabolome, microbiome and cell population analysis • Real cost until hospital discharge;Timepoint(s) of evaluation of this end point: 28 days and 90 days	—

Measure

Time frame

Secondary end point(s): To assess the effect of clarithromycin treatment compared to placebo treatment on the following: • 28-day mortality in the subgroup of patients with septic shock • All-cause 90-day mortality • Early sepsis response, defined by an at least 25% decrease of day 1 SOFA score on day 3 • Sepsis resolution; this is defined by an at least 25% decrease of day 1 SOFA score on day 7 • New sepsis episode until day 28. A new sepsis episode is noted in any patient who experiences at least 25% decrease of day 1 SOFA score on day 7 and who has further increase of day 7 total SOFA by at least 2 points, consequent to infection • Time until new sepsis episode. A new sepsis episode is noted in any patient who experiences at least 25% decrease of day 1 SOFA score on day 7 and who has further increase of day 7 total SOFA by at least 2 points, consequent to infection • Biomarkers of sepsis-induced immunosuppression through transcriptome, metabolome, microbiome and cell population analysis • Real cost until hospital discharge;Timepoint(s) of evaluation of this end point: 28 days and 90 days

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Countries

Belgium, Greece

Contacts

Public ContactChairman of the Board of Directors

HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS

insepsis@otenet.gr00302107480662

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 17, 2026