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Intravenous Clarithromycin in Septic Syndrome

Information source: University of Athens
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sepsis; Ventilator Associated Pneumonia

Intervention: Intravenous Clarithromycin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Athens

Official(s) and/or principal investigator(s):
Evangelos J Giamarellos-Bourboulis, MD, PhD, Study Chair, Affiliation: University of Athens, Medical School, Greece
Helen Giamarellou, MD, PhD, Principal Investigator, Affiliation: University of Athens, Medical School, Greece
Apostolos Armaganidis, MD, PhD, Principal Investigator, Affiliation: University of Athens, Medical School, Greece
Charis Roussos, MD, PhD, Principal Investigator, Affiliation: University of Athens, Medical School, Greece

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

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: Influence of administration of clarithromycin on systemic inflammatory response

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

1st Department of Critical Care, Evangelismos General Hospital, Athens 106 72, Greece

2nd Department of Critical Care, ATTIKON University Hospital, Athens 124 64, Greece

4th Department of Internal Medicine, ATTIKON University Hospital, Athens 124 64, Greece

Additional Information

Related 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.

Starting date: June 2004
Last updated: February 27, 2006

Page last updated: August 23, 2015

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