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REACT: Biomarker-Guided Early Clarithromycin Treatment to Prevent Sepsis Progression in CAP
NCT06294600Phase 3
Key facts
- Status
- Recruiting
- Start
- Feb 2024
- Primary completion
- Apr 2026
- Countries
- 1
- Sponsor
- Hellenic Institute for the Study of Sepsis
- Modality
- Small Molecules
- Drugs
- clarithromycin
- Conditions
- community acquired pneumonia (CAP)
01
Overview
Phase 3, randomised, double-blind trial in community acquired pneumonia (CAP) comparing Placebo with Clarithromycin (2 arms). Primary endpoints: Change of baseline respiratory symptoms score at 4 days, Change of baseline total sequential organ failure assessment score at 4 days and 1 more. Started Feb 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo tablet every 12 hours for 7 days + SoC antibiotics
Clarithromycin
Clarithromycin 500 mg twice daily for 7 days + SoC antibiotics
03
Who it enrols
Adults with community-acquired pneumonia, PCT >=0.25 ng/ml, and suPAR >=6 ng/ml, excluding those needing mechanical ventilation, ICU admission, or with SARS-CoV-2 infection.
04
Endpoints
Primary
Change of baseline respiratory symptoms score
Change of baseline total sequential organ failure assessment score
Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio
Secondary
Resolution of CAP at the test of cure (TOC) visit
Need for up-escalation of the SoC administered antibiotics
Survival
Change of baseline sequential organ failure assessment score
Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio
Cytokine production
28-Day Mortality
90-Day Mortality
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