[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659393":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":40,"studyPopulation":29,"armGroups":41,"interventions":54,"overallOfficials":63,"centralContacts":67,"locations":75,"responsibleParty":89,"collaborators":29,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":29,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":118,"whyStopped":29,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of Arizona","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"empyema recurrence","if the empyema recurs and requires further treatment beyond the course in the experimental or control group","from enrollment, to 3 months post randomization",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"readmission","if patients require readmission for further treatment from either group","from enrollment to 3 months post randomization",{"measure":19,"description":20,"timeFrame":17},"unplanned procedures","if patients require unplanned procedures to further treat the empyema",{"measure":22,"description":23,"timeFrame":24},"LOS","length of stay in the hospital","from time to enrollment to discharge from the initial hospital visit",{"measure":26,"description":27,"timeFrame":28},"cost","a cost analysis comparing total healthcare cost\u002Fburden on each group","from time to enrollment to 3 months post enrollment",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","PARALLEL","one control group and one experimental group","TREATMENT",{"masking":36,"maskingDescription":37,"whoMasked":38},"SINGLE","The infectious disease specialist will be masked to the randomization of treatment, either long or short course of antibiotics, until they make their treatment recommendation for which type of antibiotic to choose",[39],"CARE_PROVIDER","The study will be conducted as follows:\n\nPatients will enter the hospital with evidence of pleural empyema (on blood work, imaging, etc.), this will then trigger a consultation to pulmonology or thoracic surgery. Once these patients are identified, they will be screened for enrollment. If considered appropriate for enrollment, they will be asked to consent. If consented, pulmonology, thoracic surgery, and infectious disease will follow the patients course and provide treatment recommendations when appropriate. To treat the empyema, patients will begin antibiotic treatment and either undergo drainage of the collection by chest tube, or by minimally invasive surgery. Once adequate source control is achieved which is defined by removal of chest tube(s) (either following isolated placement or placement during surgery), meaning, the collection has been adequately drained, the patients will be randomized to one of two groups:\n\n1. control group, those that receive 2-6 weeks of antibiotics following treatment\n2. experimental group, those that receive 7 days of antibiotics following treatment The type of antibiotic the patients receive will be determined by an infectious disease specialist. Once patients are appropriate for discharge home, they will be discharged on their remaining antibiotic course. Both groups of patients will follow up in clinic at 1 week and 4-6 weeks post-discharge. At the one-week visit they will have a pre-visit chest x-ray. At the 4-6 week visit, they will have a pre-visit CT chest. These will aid in the decision on if the patients are being adequately treated for their infection.\n\nAll workup, treatment, procedural, and follow-up patterns are current standard of care and are not experimental. The only experimental intervention is the reduction in length of antibiotic course. The type of antibiotic given does not change either based on protocol, and will be determined on a case-by-case basis based on recommendations from an infectious disease specialist. The type of drainage procedure, either chest tube or surgery, is also not experimental and will be determined by collaboration between interventional pulmonologists and thoracic surgeons, this will also be determined on a case-by-case basis as is current standard of care.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"control","ACTIVE_COMPARATOR","control group will receive standard antibiotic course, 2-6 weeks",[47],"Other: Standard medical treatment",{"label":49,"type":50,"description":51,"interventionNames":52},"experimental","EXPERIMENTAL","experimental group will receive shorter antibiotic course, 7 days",[53],"Other: shortened antibiotic course",[55,59],{"type":6,"name":56,"description":57,"armGroupLabels":58,"otherNames":29},"shortened antibiotic course","this will look at shortening the course of antibiotics to 7 days from the standard 2-6 weeks",[49],{"type":6,"name":60,"description":61,"armGroupLabels":62,"otherNames":29},"Standard medical treatment","this group will receive standard course of antibiotics, 2-6 weeks",[43],[64],{"name":65,"affiliation":5,"role":66},"Stephanie Worrell, MD","PRINCIPAL_INVESTIGATOR",[68,72],{"name":65,"role":69,"phone":70,"phoneExt":29,"email":71},"CONTACT","520-621-1857","sworrell@arizona.edu",{"name":73,"role":69,"phone":29,"phoneExt":29,"email":74},"Kameron Durante, DO","kldurante1@arizona.edu",[76],{"facility":77,"status":29,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":29},"Banner University Medical Center Tucson","Tucson","Arizona","85714","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-110.92648,32.22174,{"lat":87,"lon":86},{"type":66,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Stephanie Worrell","Interim Division Chief, Division of Cardiothoracic Surgery","100659393","evaluating-antibiotic-course-upon-adequate-treatment-of-empyema-100659393",false,"NCT07862361","Evaluating Antibiotic Course Upon Adequate Treatment of Empyema","EvACUATE Trial, Evaluating Antibiotic Course Upon Adequate Treatment of Empyema","EvACUATE","Inclusion Criteria:\n\n* adults with pleural empyema\n\nExclusion Criteria:\n\n* Subjects must not be, younger than 18 or older than 99 years of age, have ongoing evidence of fungal infection, tuberculosis, malignant effusions or cancer involving the lungs\u002Fpleura, pregnancy, immunocompromised patients, \\& patients with concurrent secondary infections requiring additional antibiotic therapy","ALL","18 Years","99 Years",{"count":104,"type":105},50,"ESTIMATED","INTERVENTIONAL",[108],"NA","The study compares treatment strategies for treatment of pleural empyema (infected fluid in the chest). It will compare standard of care antibiotic course, 2-6 weeks, to a shorter course of antibiotics, 7 days. This course is started once patients achieve adequate source control\u002Fdrainage of the infected fluid collection. All other treatments and interventions in patients such as blood work, imaging, vitals, and surgery\u002Fprocedures follows current standard of care and are not experimental.",[111],"Pleural Empyema",[113,114,115,116,117],"pleural empyema","empyema","antibiotic course","antibiotic stewardship","source control","NOT_YET_RECRUITING","2026-10-01",{"date":121,"type":122},"2026-10-07","ACTUAL",{"date":124,"type":105},"2026-11-16",{"date":126,"type":105},"2027-08",{"name":5,"class":6},1]