Intravenous Clarithromycin in Septic Syndrome

Phase 4

Completed

• Conditions: Sepsis; Ventilator Associated Pneumonia

• Registration Number: NCT00297674
• Lead Sponsor: University of Athens

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2004-06
• Status Verified: 2004-07
• Study Completion: 2005-12
• Study First Submitted: 2006-02-27
• Study First Submitted QC: 2006-02-27
• Last Update Submitted: 2006-02-27
• Study First Posted: 2006-02-28
• Last Update Posted: 2006-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Influence of administration of clarithromycin on systemic inflammatory response

Trial Locations

Locations (3)

4th Department of Internal Medicine, ATTIKON University Hospital; 🇬🇷 Athens, Greece

2nd Department of Critical Care, ATTIKON University Hospital; 🇬🇷 Athens, Greece

1st Department of Critical Care, Evangelismos General Hospital; 🇬🇷 Athens, Greece