[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591201":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":55,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":26,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":26,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Seoul Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Piperacillin\u002FTazobactam Monotherapy","EXPERIMENTAL","Patients receive empirical treatment with piperacillin\u002Ftazobactam alone for severe community-acquired pneumonia. The antibiotic is administered according to standard dosing guidelines for hospitalized patients.",[13],"Drug: Piperacillin\u002FTazobactam",{"label":15,"type":16,"description":17,"interventionNames":18},"Piperacillin\u002FTazobactam Plus Levofloxacin Combination Therapy","ACTIVE_COMPARATOR","Patients receive empirical combination treatment with piperacillin\u002Ftazobactam and levofloxacin for severe community-acquired pneumonia. Both antibiotics are administered concurrently according to institutional protocols for combination therapy.",[19],"Drug: Piperacillin\u002Ftazobactam + Levofloxacin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Piperacillin\u002FTazobactam","Piperacillin\u002Ftazobactam: 4.5g IV q6h (over 3h)",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Piperacillin\u002Ftazobactam + Levofloxacin","Piperacillin\u002Ftazobactam: 4.5g IV q6h (over 3h)\n\n\\+ Levofloxacin 750mg IV q24h (over 30min)",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"CHOSEOK YOON, MD","CONTACT","+821024893231","yooncho119@naver.com",[38],{"facility":39,"status":26,"city":40,"state":40,"zip":41,"country":42,"countryCode":26,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hanyang University Seoul Hospital","Seoul","04761","South Korea",{"type":44,"coordinates":45},"Point",[46,47],126.9784,37.566,{"lat":47,"lon":46},[50,52],{"name":51,"role":34,"phone":35,"phoneExt":26,"email":36},"CHOSEOK YOON",{"name":53,"role":54,"phone":26,"phoneExt":26,"email":26},"BONGYOUNG KIM, MD, PHD","PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":51,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Clinical Professor, Division of Infectious Diseases, Department of Internal Medicine, Hanyang University Hospital, Seoul, South Korea","100591201","appropriateness-of-antibiotic-combination-therapy-for-severe-community-acquired-pneumonia-in-south-korea-100591201",false,"NCT06977347","Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea","Verification of Anti-pseudomonal Antibiotic Combination Therapy in Severe Community-acquired Pneumonia in South Korea: A Randomized-controlled Study","ACTSCAP","* Inclusion Criteria:\n\n  * Adult patients aged 19 years or older who visited the emergency department and were hospitalized.\n  * Findings consistent with pneumonia diagnosis, meeting all of the following criteria:\n  * Radiologic evidence of pulmonary infiltration on chest X-ray or chest CT.\n  * At least two or more of the following clinical signs:\n\n    i) Body temperature ≥38°C or \\\u003C36°C ii) White blood cell count ≥11,000\u002FµL or \\\u003C4,000\u002FµL iii) Presence of purulent sputum or bronchial secretions\n  * Within 24 hours of admission, the patient meets one major criterion or three minor criteria according to ATS\u002FIDSA classification:\n\n    * Major criteria:\n\n      i) Invasive mechanical ventilation ii) Use of vasopressors (vasopressor-dependent septic shock)\n    * Minor criteria:\n\n      i) Respiratory rate ≥30 breaths\u002Fmin ii) PaO2\u002FFiO2 ≤ 250 iii) Multilobar infiltrates iv) Confusion or disorientation v) BUN ≥20 mg\u002FdL vi) WBC \\\u003C4,000\u002Fmm³ vii) Platelet count \\\u003C100,000\u002Fmm³ viii) Hypothermia (temperature \\\u003C36°C) ix) Hypotension requiring aggressive fluid resuscitation\n* Exclusion Criteria:\n\n  * Transferred from another hospital after \\>48 hours of hospitalization\n  * Died within 72 hours of hospital admission\n  * Transferred to another hospital within 14 days of admission\n  * Pneumonia occurring after \\>48 hours of mechanical ventilation, including home ventilators\n  * Detection of influenza or SARS-CoV-2 virus within 7 days of hospitalization\n  * Identified non-pneumonia infection requiring antibiotics within 72 hours of admission\n  * Detection of piperacillin\u002Ftazobactam-resistant Enterobacterales, Pseudomonas spp., or Acinetobacter spp. in respiratory or blood cultures within the past 90 days\n  * Antibiotic-related adverse events observed within 72 hours of assigned treatment, requiring discontinuation or change of antibiotics","ALL","19 Years",{"count":69,"type":70},100,"ESTIMATED","INTERVENTIONAL",[73],"NA","This study aims to provide high-level evidence for appropriate empirical antibiotic use tailored to the clinical reality in Korea by conducting a randomized controlled trial comparing monotherapy with piperacillin\u002Ftazobactam and combination therapy with piperacillin\u002Ftazobactam plus a fluoroquinolone in patients with severe community-acquired pneumonia.",[76],"Severe Community-acquired Pneumonia (sCAP)","NOT_YET_RECRUITING","2025-05-09",{"date":80,"type":81},"2025-05-18","ACTUAL",{"date":83,"type":70},"2025-06-15",{"date":85,"type":70},"2027-02-01",{"name":51,"class":6},1]