Intravenous Clarithromycin in Septic Syndrome

February 27, 2006 updated by: University of Athens

Clarithromycin as Immunomodulatory Therapy for the Management of Septic Syndrome by Ventilator-Associated Pneumonia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 106 72
        • 1st Department of Critical Care, Evangelismos General Hospital
      • Athens, Greece, 124 64
        • 2nd Department of Critical Care, ATTIKON University Hospital
      • Athens, Greece, 124 64
        • 4th Department of Internal Medicine, Attikon University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Influence of administration of clarithromycin on systemic inflammatory response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Investigators

  • Study Chair: Evangelos J Giamarellos-Bourboulis, MD, PhD, University of Athens, Medical School, Greece
  • Principal Investigator: Helen Giamarellou, MD, PhD, University of Athens, Medical School, Greece
  • Principal Investigator: Apostolos Armaganidis, MD, PhD, University of Athens, Medical School, Greece
  • Principal Investigator: Charis Roussos, MD, PhD, University of Athens, Medical School, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

February 27, 2006

First Submitted That Met QC Criteria

February 27, 2006

First Posted (Estimate)

February 28, 2006

Study Record Updates

Last Update Posted (Estimate)

February 28, 2006

Last Update Submitted That Met QC Criteria

February 27, 2006

Last Verified

July 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACA-GREC-2004-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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