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Intravenous Clarithromycin for Sepsis
NCT01223690Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2007
- Primary completion
- Nov 2010
- Countries
- 1
- Sponsor
- National and Kapodistrian University of Athens
- Modality
- Small Molecules
- Drugs
- clarithromycin
- Conditions
- sepsisseptic shock
01
Overview
Phase 3, randomised, double-blind trial in sepsis and septic shock comparing Placebo with Clarithromycin (2 arms). Primary endpoint: Mortality and risk for death by severe sepsis/shock and multiple organ dysfunction at 28 days. Started Jul 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
250 ml of dextrose 5% administered intravenously within one hour of continuous infusion for four consecutive days
Clarithromycin
1000 mg of clarithromycin diluted in 250 ml of dextrose 5% administered intravenously within one hour of continuous infusion for four consecutive days
03
Who it enrols
Patients with sepsis caused by Gram-negative bacteremia, acute pyelonephritis, or intraabdominal infection, excluding those with HIV, severe neutropenia, or on high-dose corticosteroids.
04
Endpoints
Primary
Mortality and risk for death by severe sepsis/shock and multiple organ dysfunction
Secondary
Time to resolution of infection
Time to resolution of sepsis
Time to progression to severe sepsis or septic shock and multiple organ failure
Influence of administration of clarithromycin on systemic inflammatory response
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