[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514518":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":120,"collaborators":122,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":130,"sex":136,"minAge":18,"maxAge":18,"enrollmentInfo":137,"targetDuration":18,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":150,"overallStatus":64,"whyStopped":18,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"National University of Singapore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","ACTIVE_COMPARATOR","Samples from patients randomised to the intervention arm will undergo the BioFire FilmArray systems. Patients will be then administered with the study drug, ceftazidime-avibactam when Pseudomonas aeruginosa or carbapenemase producing Enterobacterales detected.",[13],"Diagnostic Test: Rapid Diagnostics",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics treatment will be administered as per usual institutional practice from hospital supplies.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Rapid Diagnostics","Patients randomised to the intervention arm, will have the BioFire Blood Culture Identification 2 Panel (BCID2) used for positive blood cultures and\u002For the BioFire FilmArray Pneumonia plus PanelPneumonia Panel or Pneumonia plus Panel for respiratory tract specimens if having hospital-acquired pneumonia or ventilator-associated pneumonia. Standard of care diagnostics will also be used. Antibiotic guidelines will be provided to clinicians to aid interpretation of test results and treatment prescription. Ceftazidime-avibactam will be available for targeted use in patients with Pseudomonas aeruginosa or carbapenemase producing Enterobacterales.",[9],[26,27,28],"BioFire FilmArray BCID2","BioFire FilmArray Pneumonia Plus Panel","BioFire FilmArray Pneumonia Panel",[30],{"name":31,"affiliation":5,"role":32},"David Paterson, Professor","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":18,"email":38},"Kithalakshmi Vignesvaran","CONTACT","90300178","kitha@nus.edu.sg",[40,62,83,101],{"facility":41,"status":42,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University Malaya Medical Centre","NOT_YET_RECRUITING","Kuala Lumpur","50603","Malaysia","MY",{"type":48,"coordinates":49},"Point",[50,51],101.68653,3.1412,{"lat":51,"lon":50},[54,57,59],{"name":55,"role":36,"phone":18,"phoneExt":18,"email":56},"Norhabibah","nhabibahmohd11@gmail.com",{"name":58,"role":32,"phone":18,"phoneExt":18,"email":18},"Helmi Sulaiman, Dr",{"name":60,"role":61,"phone":18,"phoneExt":18,"email":18},"Ong Hang Cheng, Dr","SUB_INVESTIGATOR",{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Taichung Veterans General Hospital","RECRUITING","Taichung","Xitun District","1650","Taiwan","TW",{"type":48,"coordinates":71},[72,73],120.6839,24.1469,{"lat":73,"lon":72},[76,79,81],{"name":77,"role":36,"phone":18,"phoneExt":18,"email":78},"Ying-Lan Li","yinglanli.vghtc@gmail.com",{"name":80,"role":32,"phone":18,"phoneExt":18,"email":18},"Po-Yu Liu, Dr",{"name":82,"role":61,"phone":18,"phoneExt":18,"email":18},"Chien-Hao Tseng, Dr",{"facility":84,"status":42,"city":85,"state":18,"zip":18,"country":68,"countryCode":69,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Kaohsiung Medical University Hospital","Kaohsiung City",{"type":48,"coordinates":87},[88,89],120.31333,22.61626,{"lat":89,"lon":88},[92,95,97,99],{"name":93,"role":36,"phone":18,"phoneExt":18,"email":94},"Hannah Yan-Zhen Hsu","hannah.hsu530@gmail.com",{"name":96,"role":32,"phone":18,"phoneExt":18,"email":18},"Po-Liang Lu, Prof",{"name":98,"role":61,"phone":18,"phoneExt":18,"email":18},"Shang-yi Lin, Dr",{"name":100,"role":61,"phone":18,"phoneExt":18,"email":18},"Ya-Ting Chang, Dr",{"facility":102,"status":42,"city":103,"state":18,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Sunpasitthiprasong Hospital","Ubon Ratchathani","34000","Thailand","TH",{"type":48,"coordinates":108},[109,110],104.84866,15.23844,{"lat":110,"lon":109},[113,116,118],{"name":114,"role":36,"phone":18,"phoneExt":18,"email":115},"Sornsuda Setaphan, Ms","Sornsuda@tropmedres.ac",{"name":117,"role":32,"phone":18,"phoneExt":18,"email":18},"Suwatthiya Kitsaran, Dr",{"name":119,"role":61,"phone":18,"phoneExt":18,"email":18},"Chamnan Parinya, Dr",{"type":121,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[123,126],{"name":124,"class":125},"Pfizer","INDUSTRY",{"name":127,"class":125},"Biomerieux inc","100514518","phase-4-early-impact-therapy-with-ceftazidime-avibactam-via-rapid-diagnostics-100514518",false,"NCT05979545","EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics","EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics Versus Standard of Care Antibiotics and Diagnostics in Patients With Bloodstream Infection, Hospital-acquired Pneumonia or Ventilator-associated Pneumonia Due to Pseudomonas Aeruginosa or Carbapenemase Producing Enterobacterales (RAPID)","RAPID","Inclusion Criteria:\n\n1. patient developed clinical symptoms compatible with bloodstream infection, hospital-acquired or ventilator-associated pneumonia (hospital-acquired and ventilator-associated pneumonia should fulfil US CDC NHSN criteria) AND,\n2. an appropriate specimen has been received by the participating laboratory - that is, a blood culture bottle showing Gram negative bacilli or a respiratory sample collected for clinical purposes showing Gram negative bacilli on Gram stain;\n\nExclusion Criteria:\n\n1. Refractory shock or comorbid condition such that patient not expected to survive more than 48 hours; OR,\n2. where the bloodstream infection is thought to be related to a vascular catheter and the catheter is unable to be removed; OR,\n3. treatment is not with the intent to cure the infection; OR,\n4. patient is incarcerated in a correctional facility; OR,\n5. patients previously randomised in this trial within the last 60 days.","ALL",{"count":138,"type":139},1900,"ESTIMATED","INTERVENTIONAL",[142],"PHASE4","The goal of this clinical trial is to propose a seamless intervention linking rapid bacterial isolate identification and antibiotic resistance gene detection and targeted antibiotic prescription to minimise time between infection onset and appropriate treatment in patients with Pseudomonas aeruginosa or carbapenemase producing Enterobacterales infections. This is an investigator initiated trial.\n\nThe primary hypothesis is that these interventions will lead to improved clinical outcomes amongst patients with hospital-acquired bloodstream infection, hospital-acquired pneumonia or ventilator-associated pneumonia due to carbapenem non-susceptible Pseudomonas aeruginosa or Enterobacterales, compared to standard antibiotic susceptibility testing.\n\nPatients will be randomised to either a control or intervention arm. Patients randomised to the intervention arm will have relevant specimens analysed by rapid microbiological diagnostics and will have early availability of ceftazidime-avibactam if appropriate. Patients randomised to the control arm, will have samples analysed by clinical microbiology laboratories using standard of care diagnostics. Antibiotics will be available to these patients as per usual institutional practice.",[145,146,147,148,149],"Blood Stream Infections","Ventilator Associated Pneumonia","Healthcare Associated Infection","Carbapenem-Resistant Enterobacteriaceae Infection","Hospital-acquired Pneumonia",[151,152,153,154,155,156,157,158,159,160],"rapid diagnostics","ceftazidime-avibactam","carbapenemase producing Enterobacterales","hospital-acquired","MDR","AMR","ASP","CRE","BCID2","PN Plus","2024-03-03",{"date":163,"type":164},"2024-03-06","ACTUAL",{"date":166,"type":164},"2023-12-12",{"date":168,"type":139},"2026-12-31",{"name":5,"class":6},4]