drugset / Trial / NCT06294600

Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)

NCT06294600

Phase 3 Recruiting 330 enrolled Hellenic Institute for the Study of Sepsis
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of the REACT randomized clinical trial (RCT) is to optimize the clinical benefit from adjunctive clarithromycin treatment shown in the ACCESS trial and to provide evidence for the clinical benefit of early start of adjunctive oral clarithromycin guided by suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia (CAP) at risk. This can be achieved by endpoints incorporating clinical benefit with the effect of treatment on the improvement of the immune dysregulation of CAP. The secondary objectives of REACT are to investigate the impact of early adjunctive treatment with clarithromycin on the resolution of CAP at the test-of-cure (TOC) visit.

Timeline

Start
2024-02-12
Primary completion
2026-04-05
Completion
2026-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clarithromycin Small molecule 500 mg Oral

Indications