Intravenous Clarithromycin in Septic Syndrome

University of Athens200 enrolled

Overview

The aim of this clinical trial is to clarify the clinical efficacy of clarithromycin as immunotherapy for the management of septic syndrome by ventilator-associated pneumonia.

The rationale of the trial is based on the favorable results of experimental studies of sepsis by multidrug-resistant Pseudomonas aeruginosa and by susceptible Escherichia coli in rabbits where clarithromycin was administered intravenously. Data from these latter studies suggest that administration of clarithromycin extended survival and attenuated systemic inflammatory response. Their major endpoint was successful immunotherapy achieved when clarithromycin was administered on presentation of symptoms of sepsis-induced pulmonary edema; on the contrary, former clinical trials for immunotherapies of sepsis were based on animal studies where the under evolution immunomodulator was administered before bacterial challenge. The efficacy of administration of clarithromycin upon presentation of septic syndrome in animal studies, renders its application promising in the clinical field.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Sepsis Ventilator Associated Pneumonia

Interventions

Intravenous ClarithromycinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. written informed consent provided by first or second degree relatives; 2. intubation and mechanical ventilation at least 48 hours prior to enrolment; c) age of patients equal to or more than 18 years; d) diagnosis of Ventilator Associated Pneumonia; and e) signs of sepsis Exclusion Criteria: 1. neutropenia, defined as less than 500 neutrophils/mm3; 2. HIV infection; 3. oral intake of corticosteroids at a dose equal to or higher than 1mg/kg equivalent prednisone for a period greater than one month; 4. administration of drotrecogin alpha the last five days prior to enrolment; and e) atrioventricular block of second or third degree.

Locations (3)

1st Department of Critical Care, Evangelismos General Hospital

Athens, Greece

2nd Department of Critical Care, ATTIKON University Hospital

Athens, Greece

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, Greece

Outcomes

Primary Outcomes

Estimation of crude mortality by any reason of each study group

Estimation of attributable mortality by VAP of each study group

7-day mortality rate of each group

28-mortality rate of each group

Rate of progression to multiple organ failure and septic shock (and number of failing organs) of each study group

Time to progression to multiple organ failure and septic shock of each study group

Days of resolution of VAP

Days in ICU after diagnosis of VAP

Secondary Outcomes

Influence of administration of clarithromycin on systemic inflammatory response

Data from ClinicalTrials.gov

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