nctId: NCT06294600 id: REACT id: 2023-507295-40 type: EUDRACT_NUMBER briefTitle: Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) acronym: REACT overallStatus: RECRUITING date: 2024-02-12 date: 2025-11-05 date: 2026-01-30 date: 2024-03-05 date: 2024-04-25 name: Hellenic Institute for the Study of Sepsis class: OTHER briefSummary: 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. conditions: Community-acquired Pneumonia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, 1:1 randomized, double-blind, placebo-controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 330 type: ESTIMATED name: Clarithromycin 500mg name: Tablets measure: Change of baseline respiratory symptoms score measure: Change of baseline total sequential organ failure assessment (SOFA) score measure: Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio measure: The number of patients that succeeded the resolution of CAP at the test of cure (TOC) visit. measure: Need for up-escalation of the SoC administered antibiotics. measure: Survival measure: Change of baseline sequential organ failure assessment (SOFA) score measure: Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio measure: Cytokine production measure: 28-Day Mortality measure: 90-Day Mortality measure: Cost sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming" status: NOT_YET_RECRUITING city: Athens country: Greece name: Nikolaos Tsokos, MD, PhD role: CONTACT phone: 6973388487 email: ntsokos@hotmail.com lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki status: NOT_YET_RECRUITING city: Athens country: Greece name: Simeon Metallidis, MD, PhD role: CONTACT phone: 6944361931 email: metallidissimeon@yahoo.gr lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: Theano Kontopoulou, MD, PhD role: CONTACT phone: 6944690525 email: tkontopoulou@yahoo.gr lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital status: RECRUITING city: Athens country: Greece name: Georgios Adamis, MD, PhD role: CONTACT phone: 6937463999 email: geo.adamis@gmail.com lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, General University Hospital of Ioannina status: NOT_YET_RECRUITING city: Athens country: Greece name: Charalampos Milionis, MD, PhD role: CONTACT phone: 6944521512 email: hmilioni@uoi.gr lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital status: RECRUITING city: Athens country: Greece name: Vassiliki Tzavara, MD, PhD role: CONTACT phone: 6944849808 phoneExt: 0030 email: vtzavara2015@gmail.com lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, THRIASIO General Hospital of Elefsis status: RECRUITING city: Athens country: Greece name: Styliani Sympardi, MD, PhD role: CONTACT phone: 6971863078 email: lianasympa@hotmail.com lat: 37.97945 lon: 23.71622 facility: 1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens status: RECRUITING city: Athens country: Greece name: Petros Bakakos, MD, PhD role: CONTACT phone: 6974748113‬ email: petros44@hotmail.com lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, Attikon University Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: Eleni Mpoutati, MD, PhD role: CONTACT phone: 6932434399 phoneExt: 0030 email: eboutati@med.uoa.gr lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, THRIASIO General Hospital of Elefsis status: NOT_YET_RECRUITING city: Athens country: Greece name: Zoi Alexiou, MD, PhD role: CONTACT phone: 6944820763 email: z_alexiou@yahoo.gr lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, TZANEIO Piraeus General Hospital status: RECRUITING city: Athens country: Greece name: Georgios Chrysos, MD, PhD role: CONTACT phone: 6945432120 email: gchrysos@gmail.com lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis status: NOT_YET_RECRUITING city: Athens country: Greece name: Periklis Panagopoulos, MD, PhD role: CONTACT phone: 6944410495 email: ppanago@med.duth.gr lat: 37.97945 lon: 23.71622 facility: 3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital status: RECRUITING city: Athens country: Greece name: Ilias Skopelitis, MD, PhD role: CONTACT phone: 6944688196 email: iskopelitis@hotmail.com lat: 37.97945 lon: 23.71622 facility: 3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO- BENAKEIO E.E.S. status: RECRUITING city: Athens country: Greece name: Maria Chini, MD, PhD role: CONTACT phone: 6944576476 email: mariachini@gmail.com lat: 37.97945 lon: 23.71622 facility: 3rd University Department of Internal Medicine, SOTIRIA Athens General Hospital of Chest Diseases status: RECRUITING city: Athens country: Greece name: Garyfallia Poulakou, MD, PhD role: CONTACT phone: 6945597583 email: gpoulakou@gmail.com lat: 37.97945 lon: 23.71622 facility: 4th Department of Internal Medicine, Attikon University Hospital status: RECRUITING city: Athens country: Greece name: Antonios Papadopoulos, MD, PhD role: CONTACT phone: 6977302400 phoneExt: 0030 email: antpapa1@otenet.gr lat: 37.97945 lon: 23.71622 facility: 6th Pulmonary Medicine Department, SOTIRIA General Hospital of Chest Diseases of Athens status: NOT_YET_RECRUITING city: Athens country: Greece name: Ioannis Dimitroulis, MD, PhD role: CONTACT phone: 6932666007 email: idimit@hotmail.com lat: 37.97945 lon: 23.71622 facility: Department of Chest Medicine, EVANGELISMOS Athens General Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: Paraskevi Katsaounou, MD, PhD role: CONTACT phone: 2132033384 phoneExt: 0030 email: paraskevikatsaounou@gmail.com lat: 37.97945 lon: 23.71622 facility: Department of Internal Medicine, Larissa University General Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: George Dalekos, MD, PhD role: CONTACT phone: 6937759699 email: georgedalekos@gmail.com lat: 37.97945 lon: 23.71622 facility: Department of Internal Medicine, Patras University General Hospital status: RECRUITING city: Athens country: Greece name: Karolina Akinosoglou, MD, PhD role: CONTACT phone: 6977762897 email: akin@upatras.gr lat: 37.97945 lon: 23.71622 facility: Department of Pulmonary Medicine, General Hospital of Kerkira status: NOT_YET_RECRUITING city: Athens country: Greece name: Ilias Papanikolaou, MD, PhD role: CONTACT phone: 6974305925 email: icpapanikolaou@hotmail.com lat: 37.97945 lon: 23.71622 facility: Emergency Department, TZANEIO Piraeus General Hospital status: RECRUITING city: Athens country: Greece name: Styliani Gerakari, MD, PhD role: CONTACT phone: 6973308684 email: sgerakari76@gmail.com lat: 37.97945 lon: 23.71622 hasResults: False