[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591201":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":43,"interventions":56,"overallOfficials":36,"centralContacts":66,"locations":72,"responsibleParty":90,"collaborators":36,"id":93,"slug":36,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":36,"enrollmentInfo":102,"targetDuration":36,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":36,"overallStatus":111,"whyStopped":36,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Seoul Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"All-cause 28-day mortality","Mortality from any cause within 28 days of randomization.","28 days",[14,18,21,24,28,32],{"measure":15,"description":16,"timeFrame":17},"Need for mechanical ventilation","Proportion of patients requiring invasive mechanical ventilation during hospitalization.","Up to hospital discharge or 28 days, whichever comes first",{"measure":19,"description":20,"timeFrame":17},"ICU admission rate","Proportion of patients who require admission to the intensive care unit (ICU) during hospitalization",{"measure":22,"description":23,"timeFrame":17},"Length of hospital stay","Total number of days from admission to discharge",{"measure":25,"description":26,"timeFrame":27},"Time to fever resolution","Time in days from initiation of antibiotic treatment to the first documented temperature \\\u003C 37.8°C maintained for at least 24 hours without antipyretic use","Up to 7 days after treatment initiation",{"measure":29,"description":30,"timeFrame":31},"Antibiotic-related adverse events","Incidence of adverse drug reactions associated with study antibiotics (e.g., gastrointestinal symptoms, allergic reactions, hepatotoxicity, nephrotoxicity) as assessed by the treating physician","From first dose to 28 days post-treatment",{"measure":33,"description":34,"timeFrame":35},"14-day hospital readmission rate","Proportion of patients who are readmitted to any hospital for any cause within 14 days after completion of antibiotic therapy","14 days after end of antibiotic treatment",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"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.",[49],"Drug: Piperacillin\u002FTazobactam",{"label":51,"type":52,"description":53,"interventionNames":54},"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.",[55],"Drug: Piperacillin\u002Ftazobactam + Levofloxacin",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":36},"DRUG","Piperacillin\u002FTazobactam","Piperacillin\u002Ftazobactam: 4.5g IV q6h (over 3h)",[45],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":36},"Piperacillin\u002Ftazobactam + Levofloxacin","Piperacillin\u002Ftazobactam: 4.5g IV q6h (over 3h)\n\n\\+ Levofloxacin 750mg IV q24h (over 30min)",[51],[67],{"name":68,"role":69,"phone":70,"phoneExt":36,"email":71},"CHOSEOK YOON, MD","CONTACT","+821024893231","yooncho119@naver.com",[73],{"facility":74,"status":36,"city":75,"state":75,"zip":76,"country":77,"countryCode":36,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Hanyang University Seoul Hospital","Seoul","04761","South Korea",{"type":79,"coordinates":80},"Point",[81,82],126.9784,37.566,{"lat":82,"lon":81},[85,87],{"name":86,"role":69,"phone":70,"phoneExt":36,"email":71},"CHOSEOK YOON",{"name":88,"role":89,"phone":36,"phoneExt":36,"email":36},"BONGYOUNG KIM, MD, PHD","PRINCIPAL_INVESTIGATOR",{"type":91,"investigatorFullName":86,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Clinical Professor, Division of Infectious Diseases, Department of Internal Medicine, Hanyang University Hospital, Seoul, 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":103,"type":104},100,"ESTIMATED","INTERVENTIONAL",[107],"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.",[110],"Severe Community-acquired Pneumonia (sCAP)","NOT_YET_RECRUITING","2025-05-09",{"date":114,"type":115},"2025-05-18","ACTUAL",{"date":117,"type":104},"2025-06-15",{"date":119,"type":104},"2027-02-01",{"name":86,"class":6},1]