septic syndrome
Conditions
Interventions
Product Name: Clarithromycin
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: clarithromycin
Current Sponsor code: J01FA09
Other descriptive name: clarithromycin
Concentration unit: mg/m
Sponsors
University of Athens, Medical school
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 >380C or 90/min; c) breath rate >20/min or Pco212,000/µl) or leukopenia (white blood cell count 10% band forms Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 ineeligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Influence of administration of clarithromycin on systemic inflammatory response;Main Objective: Mortality rate over follow-up Estimation of crude mortality by any reason of each study group Estimation of attributable mortality by sepsis of each study group Rate of progression to severe sepsis or septic shock and multiple organ failure (and number of failing organs) of each study group Time to progression to severe sepsis or septic shock and multiple organ failure of each study group Days of resolution of the infection Days of resolution of signs of sepsis Days of hospitalization;Primary end point(s): Mortality rate over follow-up Estimation of crude mortality by any reason of each study group Estimation of attributable mortality by sepsis of each study group Rate of progression to severe sepsis or septic shock and multiple organ failure (and number of failing organs) of each study group Time to progression to severe sepsis or septic shock and multiple organ failure of each study group Days of resolution of the infection Days of resolution of signs of sepsis Days of hospitalization | — |
Countries
Greece
Outcome results
None listed