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 groupEstimation 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
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