Status:
COMPLETED
Intravenous Clarithromycin in Septic Syndrome
Lead Sponsor:
University of Athens
Conditions:
Sepsis
Ventilator Associated Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
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 clarit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00297674
Start Date
June 1 2004
End Date
December 1 2005
Last Update
February 28 2006
Active Locations (3)
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1
1st Department of Critical Care, Evangelismos General Hospital
Athens, Greece, 106 72
2
2nd Department of Critical Care, ATTIKON University Hospital
Athens, Greece, 124 64
3
4th Department of Internal Medicine, ATTIKON University Hospital
Athens, Greece, 124 64