Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)

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 groups

Locations

24
5th Pulmonary Department, SOTIRIA Athens General Hospital of Chest Diseases115 27, AthensAthens, Greece
1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming" AthensGreece, Greece
1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki AthensGreece, Greece
1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital AthensGreece, Greece

Sponsors and collaborators

Hellenic Institute for the Study of Sepsis

Lead sponsor