Status:
COMPLETED
Clarithromycin as Immunomodulator for the Management of Sepsis
Lead Sponsor:
University of Athens
Conditions:
Sepsis
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The herein protocol is based on the results of one former clinical trial conducted by our study group showing the considerable efficacy of intravenously administered clarithromycin as an adjuvant to a...
Detailed Description
The idea for the application of intravenous clarithromycin as immunomodulatory therapy for the management of sepsis has been evolved on in vitro results showing that concentrations close to 10μg/ml ma...
Eligibility Criteria
Inclusion
- One or more of the following infections: a) primary or secondary bacteremia by Gram-negative bacteria, b) acute pyelonephritis, or c) intrabdominal infection. Only one episode of infection per patient will be enrolled. Both patients with community-acquired and nosocomial infections are eligible for the study.
- The presence of at least two of the following criteria of sepsis according to ACCP/SCCM (8) a) body temperature \>38 degreesC or \<36 degreesC; b) pulse rate \>90/min; c) breath rate \>20/min or Pco2\<32mmHg; and/or d) leukocytosis (white blood cell count \>12,000/μl) or leukopenia (white blood cell count \<4,000/μl) or \>10% band forms
Exclusion
- Presence of HIV infection
- Intake of corticosteroids at a dose more than or equal to 1mg/kg of equivalent prednisone for more than one month
- Neutropenia as \<500 neutrophils/μl
- Selection by the attending physician of a macrolide as empiric antimicrobial therapy for the infection making the patient eligible for the study
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01223690
Start Date
July 1 2007
End Date
April 1 2011
Last Update
August 4 2011
Active Locations (6)
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1
3rd Department of Critical Care Medicine, National and Kapodistrian University of Athens
Athens, Greece, 11528
2
2nd Department of Critical Care Medicine, National and Kapodistrian University of Athens
Athens, Greece, 12462
3
4th Department of Internal Medicine, National and Kapodistrian University of Athens
Athens, Greece, 12462
4
2nd Department of Medicine, Sismanogleion General Hospital
Athens, Greece, 15126