Intravenous Clarithromycin in Septic Syndrome - Full Text View

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:

MedlinePlus related topics: Pneumonia Sepsis Shock

Drug Information available for: Clarithromycin

U.S. FDA Resources

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:

written informed consent provided by first or second degree relatives;
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:

neutropenia, defined as less than 500 neutrophils/mm3;
HIV infection;
oral intake of corticosteroids at a dose equal to or higher than 1mg/kg equivalent prednisone for a period greater than one month;
administration of drotrecogin alpha the last five days prior to enrolment; and e) atrioventricular block of second or third degree.

Contacts and Locations

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:

Giamarellos-Bourboulis EJ, Adamis T, Laoutaris G, Sabracos L, Koussoulas V, Mouktaroudi M, Perrea D, Karayannacos PE, Giamarellou H. Immunomodulatory clarithromycin treatment of experimental sepsis and acute pyelonephritis caused by multidrug-resistant Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2004 Jan;48(1):93-9.

Giamarellos-Bourboulis EJ, Baziaka F, Antonopoulou A, Koutoukas P, Kousoulas V, Sabracos L, Panagou C, Perrea D, Giamarellou H. Clarithromycin co-administered with amikacin attenuates systemic inflammation in experimental sepsis with Escherichia coli. Int J Antimicrob Agents. 2005 Feb;25(2):168-72.

Giamarellos-Bourboulis E, Adamis T, Sabracos L, Raftogiannis M, Baziaka F, Tsaganos T, Koutoukas P, Plachouras D, Karayannacos P, Giamarellou H. Clarithromycin: immunomodulatory therapy of experimental sepsis and acute pyelonephritis by Escherichia coli. Scand J Infect Dis. 2005;37(1):48-54.

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
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013