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