Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)
ConditionCommunity-acquired Pneumonia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHellenic Institute for the Study of Sepsis
About this trial
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.
Eligibility criteria
Qualifiers
Age equal to or above 18 years
Male or female gender
In case of women of reproductive age, willingness to use dual contraceptive method during the study period
Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national legislation
Disqualifiers
Age below 18 years
Denial of written informed consent
Any stage IV malignancy
Any do not resuscitate decision
Trial design
Treatments tested in this trial
- Clarithromycin 500mg
- Tablets
Treatment groups
330 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov