Intravenous Clarithromycin in Septic Syndrome

This study has been completed.
Sponsor:
Information provided by:
University of Athens
ClinicalTrials.gov Identifier:
NCT00297674
First received: February 27, 2006
Last updated: NA
Last verified: July 2004
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Sepsis
Ventilator Associated Pneumonia
Drug: Intravenous Clarithromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Clarithromycin as Immunomodulatory Therapy for the Management of Septic Syndrome by Ventilator-Associated Pneumonia

Resource links provided by NLM:


Further study details as provided by University of Athens:

Primary Outcome Measures:
  • 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:
  • Influence of administration of clarithromycin on systemic inflammatory response

Estimated Enrollment: 200
Study Start Date: June 2004
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00297674

Locations
Greece
2nd Department of Critical Care, ATTIKON University Hospital
Athens, Greece, 124 64
4th Department of Internal Medicine, ATTIKON University Hospital
Athens, Greece, 124 64
1st Department of Critical Care, Evangelismos General Hospital
Athens, Greece, 106 72
Sponsors and Collaborators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00297674     History of Changes
Other Study ID Numbers: ACA-GREC-2004-01
Study First Received: February 27, 2006
Last Updated: February 27, 2006
Health Authority: Greece: National Organization of Medicines

Keywords provided by University of Athens:
clarithromycin
sepsis
immunomodulation

Additional relevant MeSH terms:
Pneumonia
Sepsis
Systemic Inflammatory Response Syndrome
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Inflammation
Pathologic Processes
Shock
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014