[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538727":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":49,"responsibleParty":303,"collaborators":47,"id":305,"slug":306,"hasResults":307,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":307,"sex":313,"minAge":314,"maxAge":47,"enrollmentInfo":315,"targetDuration":47,"studyType":318,"phases":319,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":52,"whyStopped":47,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},{"fullName":5,"class":6},"Hellenic Institute for the Study of Sepsis","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","These patients will be treated with 1 placebo tablet every 12 hours and it is suggested that all patients receive at least one of antibiotics based on the current ESCMID guidelines for severe CAP13 (Ampicillin\u002Fsulbactam, Amoxicillin\u002Fclavulanate, Piperacillin\u002Ftazobactam, Ceftriaxone, Cefotaxime, Ceftaroline, Moxifloxacin). The total duration of treatment will be seven days.Τhe dosage, the dosage regime, the route and mode of administration, and the treatment period for the aforementioned antibiotics can be found in the relevant SmPCs (available in References). However, the attending physician may modify the antimicrobial treatment based on risk factors for multidrug-resistance pathogens, microbiology results and local epidemiology. All SoC treatment products and clarithromycin are authorised for use in Greece, where the trial will be conducted.",[13],"Drug: Tablets",{"label":15,"type":16,"description":17,"interventionNames":18},"Clarithromycin","ACTIVE_COMPARATOR","These patients will be treated with oral clarithromycin 500 mg twice daily for seven days and it is suggested that all patients receive at least one of antibiotics based on the current ESCMID guidelines for severe CAP13 (Ampicillin\u002Fsulbactam, Amoxicillin\u002Fclavulanate, Piperacillin\u002Ftazobactam, Ceftriaxone, Cefotaxime, Ceftaroline, Moxifloxacin). The total duration of treatment will be seven days.Τhe dosage, the dosage regime, the route and mode of administration, and the treatment period for the aforementioned antibiotics can be found in the relevant SmPCs (available in References). However, the attending physician may modify the antimicrobial treatment based on risk factors for multidrug-resistance pathogens, microbiology results and local epidemiology. All SoC treatment products and clarithromycin are authorised for use in Greece, where the trial will be conducted.",[19],"Drug: Clarithromycin 500mg",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Clarithromycin 500mg","Oral tablets of 500mg of clarithromycin",[15],[27],"A β-lactam\u002Fβ-lactamase inhibitor or a 3rd generation cephalosporin or a fluoroquinolone",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Tablets","Oral tablets of similar appearance to active study drug",[9],[27],[34],{"name":35,"affiliation":36,"role":37},"Evangelos J Giamarellos-Bourboulis, MD, Phd","Hellenic Sepsis Study Group","STUDY_CHAIR",[39,44],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","2105831994","0030","egiamarel@med.uoa.gr",{"name":45,"role":40,"phone":46,"phoneExt":47,"email":48},"Athanasia Chatzianastasiou, Phd","6938262747",null,"n.chatzianastasiou@sepsis.gr",[50,68,79,89,99,109,119,129,139,149,159,169,179,189,199,209,219,229,239,249,259,269,279,289],{"facility":51,"status":52,"city":53,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"5th Pulmonary Department, SOTIRIA Athens General Hospital of Chest Diseases","RECRUITING","Athens","115 27","Greece","GR",{"type":58,"coordinates":59},"Point",[60,61],23.72784,37.98376,{"lat":61,"lon":60},[64],{"name":65,"role":40,"phone":66,"phoneExt":47,"email":67},"Adamantia Liapikou","+306972017684","mliapikou@yahoo.com",{"facility":69,"status":70,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"1st Department of Internal Medicine - General Hospital of Athens \"Sismanogleio-Amalia Fleming\"","NOT_YET_RECRUITING",{"type":58,"coordinates":72},[60,61],{"lat":61,"lon":60},[75],{"name":76,"role":40,"phone":77,"phoneExt":47,"email":78},"Nikolaos Tsokos, MD, PhD","6973388487","ntsokos@hotmail.com",{"facility":80,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},"1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki",{"type":58,"coordinates":82},[60,61],{"lat":61,"lon":60},[85],{"name":86,"role":40,"phone":87,"phoneExt":47,"email":88},"Simeon Metallidis, MD, PhD","6944361931","metallidissimeon@yahoo.gr",{"facility":90,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital",{"type":58,"coordinates":92},[60,61],{"lat":61,"lon":60},[95],{"name":96,"role":40,"phone":97,"phoneExt":47,"email":98},"Theano Kontopoulou, MD, PhD","6944690525","tkontopoulou@yahoo.gr",{"facility":100,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital",{"type":58,"coordinates":102},[60,61],{"lat":61,"lon":60},[105],{"name":106,"role":40,"phone":107,"phoneExt":47,"email":108},"Georgios Adamis, MD, PhD","6937463999","geo.adamis@gmail.com",{"facility":110,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"1st Department of Internal Medicine, General University Hospital of Ioannina",{"type":58,"coordinates":112},[60,61],{"lat":61,"lon":60},[115],{"name":116,"role":40,"phone":117,"phoneExt":47,"email":118},"Charalampos Milionis, MD, PhD","6944521512","hmilioni@uoi.gr",{"facility":120,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital",{"type":58,"coordinates":122},[60,61],{"lat":61,"lon":60},[125],{"name":126,"role":40,"phone":127,"phoneExt":42,"email":128},"Vassiliki Tzavara, MD, PhD","6944849808","vtzavara2015@gmail.com",{"facility":130,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"1st Department of Internal Medicine, THRIASIO General Hospital of Elefsis",{"type":58,"coordinates":132},[60,61],{"lat":61,"lon":60},[135],{"name":136,"role":40,"phone":137,"phoneExt":47,"email":138},"Styliani Sympardi, MD, PhD","6971863078","lianasympa@hotmail.com",{"facility":140,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":141,"geoPoint":143,"contacts":144},"1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens",{"type":58,"coordinates":142},[60,61],{"lat":61,"lon":60},[145],{"name":146,"role":40,"phone":147,"phoneExt":47,"email":148},"Petros Bakakos, MD, PhD","6974748113‬","petros44@hotmail.com",{"facility":150,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":151,"geoPoint":153,"contacts":154},"2nd Department of Internal Medicine, Attikon University Hospital",{"type":58,"coordinates":152},[60,61],{"lat":61,"lon":60},[155],{"name":156,"role":40,"phone":157,"phoneExt":42,"email":158},"Eleni Mpoutati, MD, PhD","6932434399","eboutati@med.uoa.gr",{"facility":160,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":161,"geoPoint":163,"contacts":164},"2nd Department of Internal Medicine, THRIASIO General Hospital of Elefsis",{"type":58,"coordinates":162},[60,61],{"lat":61,"lon":60},[165],{"name":166,"role":40,"phone":167,"phoneExt":47,"email":168},"Zoi Alexiou, MD, PhD","6944820763","z_alexiou@yahoo.gr",{"facility":170,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":171,"geoPoint":173,"contacts":174},"2nd Department of Internal Medicine, TZANEIO Piraeus General Hospital",{"type":58,"coordinates":172},[60,61],{"lat":61,"lon":60},[175],{"name":176,"role":40,"phone":177,"phoneExt":47,"email":178},"Georgios Chrysos, MD, PhD","6945432120","gchrysos@gmail.com",{"facility":180,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":181,"geoPoint":183,"contacts":184},"2nd Department of Internal Medicine, University General Hospital of Alexandroupolis",{"type":58,"coordinates":182},[60,61],{"lat":61,"lon":60},[185],{"name":186,"role":40,"phone":187,"phoneExt":47,"email":188},"Periklis Panagopoulos, MD, PhD","6944410495","ppanago@med.duth.gr",{"facility":190,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":191,"geoPoint":193,"contacts":194},"3rd Department of Internal Medicine - General State Hospital of Nikaia \"Saint Panteleimon\" - West Attica General Hospital",{"type":58,"coordinates":192},[60,61],{"lat":61,"lon":60},[195],{"name":196,"role":40,"phone":197,"phoneExt":47,"email":198},"Ilias Skopelitis, MD, PhD","6944688196","iskopelitis@hotmail.com",{"facility":200,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":201,"geoPoint":203,"contacts":204},"3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO- BENAKEIO E.E.S.",{"type":58,"coordinates":202},[60,61],{"lat":61,"lon":60},[205],{"name":206,"role":40,"phone":207,"phoneExt":47,"email":208},"Maria Chini, MD, PhD","6944576476","mariachini@gmail.com",{"facility":210,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":211,"geoPoint":213,"contacts":214},"3rd University Department of Internal Medicine, SOTIRIA Athens General Hospital of Chest Diseases",{"type":58,"coordinates":212},[60,61],{"lat":61,"lon":60},[215],{"name":216,"role":40,"phone":217,"phoneExt":47,"email":218},"Garyfallia Poulakou, MD, PhD","6945597583","gpoulakou@gmail.com",{"facility":220,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":221,"geoPoint":223,"contacts":224},"4th Department of Internal Medicine, Attikon University Hospital",{"type":58,"coordinates":222},[60,61],{"lat":61,"lon":60},[225],{"name":226,"role":40,"phone":227,"phoneExt":42,"email":228},"Antonios Papadopoulos, MD, PhD","6977302400","antpapa1@otenet.gr",{"facility":230,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":231,"geoPoint":233,"contacts":234},"6th Pulmonary Medicine Department, SOTIRIA General Hospital of Chest Diseases of Athens",{"type":58,"coordinates":232},[60,61],{"lat":61,"lon":60},[235],{"name":236,"role":40,"phone":237,"phoneExt":47,"email":238},"Ioannis Dimitroulis, MD, PhD","6932666007","idimit@hotmail.com",{"facility":240,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":241,"geoPoint":243,"contacts":244},"Department of Chest Medicine, EVANGELISMOS Athens General Hospital",{"type":58,"coordinates":242},[60,61],{"lat":61,"lon":60},[245],{"name":246,"role":40,"phone":247,"phoneExt":42,"email":248},"Paraskevi Katsaounou, MD, PhD","2132033384","paraskevikatsaounou@gmail.com",{"facility":250,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":251,"geoPoint":253,"contacts":254},"Department of Internal Medicine, Larissa University General Hospital",{"type":58,"coordinates":252},[60,61],{"lat":61,"lon":60},[255],{"name":256,"role":40,"phone":257,"phoneExt":47,"email":258},"George Dalekos, MD, PhD","6937759699","georgedalekos@gmail.com",{"facility":260,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":261,"geoPoint":263,"contacts":264},"Department of Internal Medicine, Patras University General Hospital",{"type":58,"coordinates":262},[60,61],{"lat":61,"lon":60},[265],{"name":266,"role":40,"phone":267,"phoneExt":47,"email":268},"Karolina Akinosoglou, MD, PhD","6977762897","akin@upatras.gr",{"facility":270,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":271,"geoPoint":273,"contacts":274},"Department of Pulmonary Medicine, General Hospital of Kerkira",{"type":58,"coordinates":272},[60,61],{"lat":61,"lon":60},[275],{"name":276,"role":40,"phone":277,"phoneExt":47,"email":278},"Ilias Papanikolaou, MD, PhD","6974305925","icpapanikolaou@hotmail.com",{"facility":280,"status":52,"city":53,"state":55,"zip":47,"country":55,"countryCode":56,"cosmosGeoPoint":281,"geoPoint":283,"contacts":284},"Emergency Department, TZANEIO Piraeus General Hospital",{"type":58,"coordinates":282},[60,61],{"lat":61,"lon":60},[285],{"name":286,"role":40,"phone":287,"phoneExt":47,"email":288},"Styliani Gerakari, MD, PhD","6973308684","sgerakari76@gmail.com",{"facility":290,"status":52,"city":291,"state":291,"zip":292,"country":55,"countryCode":56,"cosmosGeoPoint":293,"geoPoint":297,"contacts":298},"3rd Department of Internal Medicine, PAPAGEORGIOU General Hospital of Thessaloniki","Thessaloniki","564 29",{"type":58,"coordinates":294},[295,296],22.93493,40.64072,{"lat":296,"lon":295},[299],{"name":300,"role":40,"phone":301,"phoneExt":47,"email":302},"Vassileios Kotsis, Professor","+306974748860","vkotsis@auth.gr",{"type":304,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100538727","phase-3-clarithromycin-treatment-to-prevent-sepsis-progression-in-cap-react-100538727",false,"NCT06294600","Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT)","Biomarker-Guided Early Elarithromycin Treatment to Prevent Sepsis Progression in Community-Acquired Pneumonia: The React Randomized Clinical Trial","REACT","Inclusion Criteria:\n\n* Age equal to or above 18 years\n* Male or female gender\n* In case of women of reproductive age, willingness to use dual contraceptive method during the study period\n* 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\n* Community-acquired pneumonia (CAP)\n* Presence of at least two of the following signs: i) cough; ii) purulent sputum expectoration; iii) dyspnea; and\u002For iv) pleuritic chest pain\n* PCT ≥0.25 ng\u002Fml\n* suPAR ≥6 ng\u002Fml\n\nExclusion Criteria:\n\n* Age below 18 years\n* Denial of written informed consent\n* Any stage IV malignancy\n* Any do not resuscitate decision\n* Patients necessitating non-invasive ventilation or mechanical ventilation\n* Hospitalization in Intensive Care Unit\n* Infection by SARS-CoV-2\n* Oral or IV intake of corticosteroids at a daily dose equal to or greater than 0.4 mg\u002Fkg prednisone for a period greater than the last 15 days\n* Intake of any macrolide for the current episode of CAP under study\n* Known infection by the human immunodeficiency virus\n* Any chronic anti-cytokine treatment for more than two months\n* QTc interval at rest in the ECG ≥500 msec or history of know long QT syndrome\n* Medical history of allergy to macrolides\n* Concomitant oral intake of astemizole, cizapride, doperidone, pimozide, terfenadine, midazolam, ranolazine, ergot alkaloids (e.g. ergotamine and dihydroergotamine), lomitapide and colchicine; patients may be enrolled in the trial if they stop these drugs during trial participation.\n* Medical history of torsades de pointes arrhythmia\n* Concomitant intake of lovostatin or simvastatin; patients may be enrolled in the trial if they stop these drugs during trial participation.\n* Concomitant presence of end-stage liver failure and end-stage renal failure.\n* Severe hypokalemia or severe hypomagnesemia; a patient may be enrolled one any of these electrolyte disturbances are restored.\n* Any contradictions for macrolide uptake\n* Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study\n* Participation in any other interventional trial within the last 30 days","ALL","18 Years",{"count":316,"type":317},330,"ESTIMATED","INTERVENTIONAL",[320],"PHASE3","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.",[323],"Community-acquired Pneumonia",[325,326,327,328,329,330,331,332],"CAP","CLARITHROMYCIN","SEPSIS","suPAR","PCT","ACCESS","SOFA","RSS","2025-12-15",{"date":335,"type":336},"2025-12-16","ACTUAL",{"date":338,"type":336},"2024-02-12",{"date":340,"type":317},"2026-07-30",{"name":5,"class":6},24]