[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557399":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":47,"centralContacts":53,"locations":64,"responsibleParty":598,"collaborators":601,"id":611,"slug":612,"hasResults":613,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":613,"sex":619,"minAge":620,"maxAge":621,"enrollmentInfo":622,"targetDuration":11,"studyType":625,"phases":626,"briefSummary":628,"conditions":629,"keywords":11,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":640},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"De-escalation VS No De-escalation","ACTIVE_COMPARATOR",null,[13],"Other: De-escalation VS No De-escalation",{"label":15,"type":10,"description":11,"interventionNames":16},"Oral beta-lactams VS Oral Non-beta-lactams",[17],"Other: Oral beta-lactams VS non beta-lactams",{"label":19,"type":10,"description":11,"interventionNames":20},"Central vascular catheter retention VS Central vascular catheter replacement",[21],"Other: Central vascular catheter retention VS Central vascular catheter replacement",{"label":23,"type":10,"description":11,"interventionNames":24},"Cephalosporin VS Carbapenem for low risk AmpC organisms",[25],"Other: Cephalosporin VS Carbapenem for low risk AmpC organisms",{"label":27,"type":10,"description":11,"interventionNames":28},"Routine follow-up blood culture VS No routine follow-up blood culture",[29],"Other: Routine follow-up blood culture VS No routine follow-up blood culture",[31,34,38,41,44],{"type":6,"name":9,"description":32,"armGroupLabels":33,"otherNames":11},"No de-escalation group: continue to receive the same antibiotic that was started initially (as long as it is confirmed to be effective based on the blood culture sensitivity result). De-escalation is only allowed within 7 days if patient is being discharged from hospital.\n\nDe-escalation group: switched to narrower spectrum antibiotic (based on spectrum scale specified in protocol).",[9],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"Oral beta-lactams VS non beta-lactams","Beta-lactam antibiotic: This can be, but not limited to, amoxicillin, amoxicillin-clavulanate, cephalexin, cefadroxil, or cefixime.\n\nNon beta-lactam antibiotic: This can be ciprofloxacin, moxifloxacin, levofloxacin or trimethoprim-sulfamethoxazole.",[15],{"type":6,"name":19,"description":39,"armGroupLabels":40,"otherNames":11},"Central vascular catheter replacement: the catheter will be changed by the treating team as soon as possible and within a maximum of 72 hours from blood culture finalization\n\nCentral vascular catheter retention: the catheter will not be changed and will be retained until it is non functional or no longer needed.",[19],{"type":6,"name":23,"description":42,"armGroupLabels":43,"otherNames":11},"Cephalosporin (ceftriaxone) at standard doses\n\nCarbapenem (Meropenem or Ertapenem) at standard doses",[23],{"type":6,"name":27,"description":45,"armGroupLabels":46,"otherNames":11},"Routine follow-up blood culture: routine repeat blood collection 4 days from the index blood collection with positive bacteria.\n\nNo follow-up blood culture: no routine repeat blood collection 4 days from the index blood collection with positive bacteria",[27],[48,51],{"name":49,"affiliation":5,"role":50},"Nick Daneman, MD","PRINCIPAL_INVESTIGATOR",{"name":52,"affiliation":5,"role":50},"Rob Fowler, MD",[54,59],{"name":49,"role":55,"phone":56,"phoneExt":57,"email":58},"CONTACT","4164806100","3862","nick.daneman@sunnybrook.ca",{"name":60,"role":55,"phone":61,"phoneExt":62,"email":63},"Mithun Mohan George","416-480-6100","688153","mithun.george@sri.utoronto.ca",[65,90,105,121,135,149,164,179,190,204,215,225,234,248,263,277,292,303,314,329,341,359,368,376,387,398,415,423,431,442,450,467,490,506,516,527,542,559,576],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"St George Hospital","RECRUITING","Kogarah","New South Wales","2217","Australia","AU",{"type":74,"coordinates":75},"Point",[76,77],151.13564,-33.9681,{"lat":77,"lon":76},[80,84,86,87],{"name":81,"role":55,"phone":82,"phoneExt":11,"email":83},"Richard Sullivan","+61 2 9113 1111","richard.sullivan@health.nsw.gov.au",{"name":85,"role":55,"phone":11,"phoneExt":11,"email":11},"Rachael Roberts, Research Coordinator",{"name":81,"role":50,"phone":11,"phoneExt":11,"email":11},{"name":88,"role":89,"phone":11,"phoneExt":11,"email":11},"Pam Konecny","SUB_INVESTIGATOR",{"facility":91,"status":67,"city":92,"state":69,"zip":11,"country":71,"countryCode":72,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"John Hunter Hospital","New Lambton",{"type":74,"coordinates":94},[95,96],151.7085,-32.92838,{"lat":96,"lon":95},[99,102,104],{"name":100,"role":55,"phone":11,"phoneExt":11,"email":101},"Joshua Davis","Joshua.Davis@health.nsw.gov.au",{"name":11,"role":55,"phone":103,"phoneExt":11,"email":11},"+61 2 4921 3000",{"name":100,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":106,"status":67,"city":107,"state":108,"zip":109,"country":71,"countryCode":72,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Royal Brisbane and Women's Hospital","Herston","Queensland","4006",{"type":74,"coordinates":111},[112,113],153.01852,-27.44453,{"lat":113,"lon":112},[116,120],{"name":117,"role":55,"phone":118,"phoneExt":11,"email":119},"Patrick Harris, Infectious Disease Physician","+61 7 3646 8111","patrick.harris2@health.qld.gov.au",{"name":117,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":122,"status":67,"city":123,"state":108,"zip":11,"country":71,"countryCode":72,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Redcliffe Hospital","Redcliffe",{"type":74,"coordinates":125},[126,127],153.10648,-27.22649,{"lat":127,"lon":126},[130,134],{"name":131,"role":55,"phone":132,"phoneExt":11,"email":133},"Kevin O'Callaghan","+61 7 3883 7777","Kevin.OCallaghan@health.qld.gov.au",{"name":131,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":136,"status":67,"city":137,"state":108,"zip":11,"country":71,"countryCode":72,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Sunshine Coast University Hospital","Sunshine Coast",{"type":74,"coordinates":139},[140,141],153.07955,-26.65682,{"lat":141,"lon":140},[144,148],{"name":145,"role":55,"phone":146,"phoneExt":11,"email":147},"Gururaj Nagaraj","+61 7 5202 0000","gururaj.nagaraj@health.oqld.gov.au",{"name":145,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":150,"status":67,"city":151,"state":152,"zip":11,"country":71,"countryCode":72,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Monash Medical Center","Clayton","Victoria",{"type":74,"coordinates":154},[155,156],145.11667,-37.91667,{"lat":156,"lon":155},[159,163],{"name":160,"role":55,"phone":161,"phoneExt":11,"email":162},"Ben Rogers","(03) 9594 6666","Ben.Rogers@monash.edu",{"name":160,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":165,"status":67,"city":166,"state":167,"zip":11,"country":71,"countryCode":72,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Fiona Stanley Hospital","Murdoch","Western Australia",{"type":74,"coordinates":169},[170,171],115.83757,-32.06987,{"lat":171,"lon":170},[174,178],{"name":175,"role":55,"phone":176,"phoneExt":11,"email":177},"Edward Raby","+61 8 6152 2222","Edward.Raby@health.wa.gov.au",{"name":175,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":180,"status":67,"city":166,"state":167,"zip":11,"country":71,"countryCode":72,"cosmosGeoPoint":181,"geoPoint":183,"contacts":184},"St John of God",{"type":74,"coordinates":182},[170,171],{"lat":171,"lon":170},[185,189],{"name":186,"role":55,"phone":187,"phoneExt":11,"email":188},"Adrian Regli","+61 8 9438 9000","adrian.regli@gmail.com",{"name":186,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":191,"status":67,"city":192,"state":193,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Foothills Hospital","Calgary","Alberta","Canada","CA",{"type":74,"coordinates":197},[198,199],-114.08529,51.05011,{"lat":199,"lon":198},[202],{"name":203,"role":55,"phone":11,"phoneExt":11,"email":11},"Ranjani Somayaji, MD",{"facility":205,"status":67,"city":192,"state":193,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":206,"geoPoint":208,"contacts":209},"Peter Lougheed Centre",{"type":74,"coordinates":207},[198,199],{"lat":199,"lon":198},[210,214],{"name":211,"role":55,"phone":212,"phoneExt":11,"email":213},"Ranjani Somayaji","(403) 943-4555","rsomayaj@ucalgary.ca",{"name":211,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":216,"status":67,"city":192,"state":193,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":217,"geoPoint":219,"contacts":220},"Rockyview General Hospital",{"type":74,"coordinates":218},[198,199],{"lat":199,"lon":198},[221,224],{"name":211,"role":55,"phone":222,"phoneExt":11,"email":223},"(403) 943-3000","rsomayaj@ucalgary.ca;kmfiest@ucalgary.ca",{"name":211,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":226,"status":67,"city":192,"state":193,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":227,"geoPoint":229,"contacts":230},"South Health Campus",{"type":74,"coordinates":228},[198,199],{"lat":199,"lon":198},[231,233],{"name":211,"role":55,"phone":232,"phoneExt":11,"email":213},"(403) 956-1111",{"name":211,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":235,"status":67,"city":236,"state":193,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"University of Alberta","Edmonton",{"type":74,"coordinates":238},[239,240],-113.46871,53.55014,{"lat":240,"lon":239},[243,247],{"name":244,"role":55,"phone":245,"phoneExt":11,"email":246},"Wendy Sligl","(780) 492-3111","wsligl@ualberta.ca",{"name":244,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":249,"status":67,"city":250,"state":251,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Surrey Memorial Hospital","Surrey","British Columbia",{"type":74,"coordinates":253},[254,255],-122.82509,49.10635,{"lat":255,"lon":254},[258,262],{"name":259,"role":55,"phone":260,"phoneExt":11,"email":261},"Kevin Afra","(604) 581-2211","Kevin.Afra@fraserhealth.ca",{"name":259,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":264,"status":67,"city":265,"state":251,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Vancouver General Hospital","Vancouver",{"type":74,"coordinates":267},[268,269],-123.11934,49.24966,{"lat":269,"lon":268},[272,276],{"name":273,"role":55,"phone":274,"phoneExt":11,"email":275},"Jennifer Grant","(604) 875-4111","Jennifer.grant@bccdc.ca",{"name":273,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":278,"status":67,"city":279,"state":280,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Grace Hospital","Winnipeg","Manitoba",{"type":74,"coordinates":282},[283,284],-97.14704,49.8844,{"lat":284,"lon":283},[287,291],{"name":288,"role":55,"phone":289,"phoneExt":11,"email":290},"Gloria Vazquez-Grande","(204) 837-0111","Gloria.Vazquez-Grande@umanitoba.ca",{"name":288,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":293,"status":67,"city":279,"state":280,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":294,"geoPoint":296,"contacts":297},"Health Sciences Centre",{"type":74,"coordinates":295},[283,284],{"lat":284,"lon":283},[298,302],{"name":299,"role":55,"phone":300,"phoneExt":11,"email":301},"Sylvain Lother","(204) 787-3661","Sylvain.Lother@umanitoba.ca",{"name":299,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":304,"status":67,"city":279,"state":280,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":305,"geoPoint":307,"contacts":308},"St. Boniface Hospital",{"type":74,"coordinates":306},[283,284],{"lat":284,"lon":283},[309,313],{"name":310,"role":55,"phone":311,"phoneExt":11,"email":312},"Terry Wuerz","(204) 233-8563","twuerz@hsc.mb.ca",{"name":310,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":315,"status":67,"city":316,"state":317,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":318,"geoPoint":322,"contacts":323},"Dr. Everett Chalmers Regional Hospital","Fredericton","New Brunswick",{"type":74,"coordinates":319},[320,321],-66.66558,45.94541,{"lat":321,"lon":320},[324,328],{"name":325,"role":55,"phone":326,"phoneExt":11,"email":327},"Rosa Rossana","(506) 452-5400","Rossana.Rosa@HorizonNB.ca",{"name":325,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":330,"status":67,"city":331,"state":332,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":333,"geoPoint":337,"contacts":338},"Eastern Regional Health Authority","St. John's","Newfoundland and Labrador",{"type":74,"coordinates":334},[335,336],-52.70931,47.56494,{"lat":336,"lon":335},[339],{"name":340,"role":55,"phone":11,"phoneExt":11,"email":11},"Peter Daley, MD",{"facility":342,"status":343,"city":344,"state":345,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":346,"geoPoint":350,"contacts":351},"Trillium Health Partners - Mississauga Hospital","NOT_YET_RECRUITING","Mississauga","Ontario",{"type":74,"coordinates":347},[348,349],-79.6583,43.5789,{"lat":349,"lon":348},[352,356,358],{"name":353,"role":55,"phone":354,"phoneExt":11,"email":355},"Christopher Graham","(905) 848-7100","Christopher.Graham@thp.ca",{"name":357,"role":55,"phone":11,"phoneExt":11,"email":11},"Mobina Khurram",{"name":353,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":360,"status":67,"city":361,"state":345,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":11,"geoPoint":11,"contacts":362},"Humber River Health system","North York",[363,367],{"name":364,"role":55,"phone":365,"phoneExt":11,"email":366},"Ian Brasg","(416) 242-1000","ibrasg@hrh.ca",{"name":364,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":369,"status":67,"city":361,"state":345,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":11,"geoPoint":11,"contacts":370},"North York General Hospital",[371,375],{"name":372,"role":55,"phone":373,"phoneExt":11,"email":374},"Pavani Das","(416) 756-6000","Pavani.Das@nygh.on.ca",{"name":372,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":377,"status":67,"city":378,"state":345,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":379,"geoPoint":383,"contacts":384},"The Ottawa Hospital","Ottawa",{"type":74,"coordinates":380},[381,382],-75.69812,45.41117,{"lat":382,"lon":381},[385],{"name":386,"role":55,"phone":11,"phoneExt":11,"email":11},"Derek McFadden, MD",{"facility":388,"status":67,"city":389,"state":345,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Niagara Health System","St. Catharines",{"type":74,"coordinates":391},[392,393],-79.24267,43.17126,{"lat":393,"lon":392},[396],{"name":397,"role":55,"phone":11,"phoneExt":11,"email":11},"Aidan Findlater, MD",{"facility":5,"status":67,"city":399,"state":345,"zip":400,"country":194,"countryCode":195,"cosmosGeoPoint":401,"geoPoint":405,"contacts":406},"Toronto","M4N3M5",{"type":74,"coordinates":402},[403,404],-79.39864,43.70643,{"lat":404,"lon":403},[407,409,412,414],{"name":49,"role":55,"phone":56,"phoneExt":408,"email":58},"2791",{"name":410,"role":55,"phone":61,"phoneExt":62,"email":411},"Archana Malavade","archana.malavade@sri.utoronto.ca",{"name":413,"role":50,"phone":11,"phoneExt":11,"email":11},"Rob A Fowler, MD",{"name":49,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":416,"status":67,"city":399,"state":345,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":417,"geoPoint":419,"contacts":420},"Michael Garron Hospital",{"type":74,"coordinates":418},[403,404],{"lat":404,"lon":403},[421],{"name":422,"role":55,"phone":11,"phoneExt":11,"email":11},"Christopher Kandel, MD",{"facility":424,"status":67,"city":399,"state":345,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":425,"geoPoint":427,"contacts":428},"Mount Sinai Hospital",{"type":74,"coordinates":426},[403,404],{"lat":404,"lon":403},[429],{"name":430,"role":55,"phone":11,"phoneExt":11,"email":11},"Michael Fralick, PhD",{"facility":432,"status":67,"city":399,"state":345,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":433,"geoPoint":435,"contacts":436},"St. Joseph's Health Centre",{"type":74,"coordinates":434},[403,404],{"lat":404,"lon":403},[437,441],{"name":438,"role":55,"phone":439,"phoneExt":11,"email":440},"Kevin Schwartz","(416) 530-6000","Kevin.Schwartz@unityhealth.to",{"name":438,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":443,"status":67,"city":399,"state":345,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":444,"geoPoint":446,"contacts":447},"University Health Network",{"type":74,"coordinates":445},[403,404],{"lat":404,"lon":403},[448],{"name":449,"role":55,"phone":11,"phoneExt":11,"email":11},"Bryan Coburn, MD",{"facility":451,"status":67,"city":452,"state":453,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":454,"geoPoint":458,"contacts":459},"CHU de Québec - Université Laval","Laval","Quebec",{"type":74,"coordinates":455},[456,457],-73.692,45.56995,{"lat":457,"lon":456},[460,464,465],{"name":461,"role":55,"phone":462,"phoneExt":11,"email":463},"Francois Lauzier","(418) 525-4444","francois.lauzier@fmed.ulaval.ca",{"name":461,"role":50,"phone":11,"phoneExt":11,"email":11},{"name":466,"role":89,"phone":11,"phoneExt":11,"email":11},"Julie Bestman-Smith",{"facility":468,"status":67,"city":452,"state":453,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":469,"geoPoint":471,"contacts":472},"Hôpital de la Cité de la Santé",{"type":74,"coordinates":470},[456,457],{"lat":457,"lon":456},[473,477,478,480,482,484,486,488],{"name":474,"role":55,"phone":475,"phoneExt":11,"email":476},"Marco Bergevin","450- 668-1010","Marco-Andres.Bergevin.med@ssss.gouv.qc.ca",{"name":474,"role":50,"phone":11,"phoneExt":11,"email":11},{"name":479,"role":89,"phone":11,"phoneExt":11,"email":11},"Stéphanie Castonguay",{"name":481,"role":89,"phone":11,"phoneExt":11,"email":11},"Olivier Haeck",{"name":483,"role":89,"phone":11,"phoneExt":11,"email":11},"Esther Simoneau",{"name":485,"role":89,"phone":11,"phoneExt":11,"email":11},"Marios Roussos",{"name":487,"role":89,"phone":11,"phoneExt":11,"email":11},"Natalie Rivest",{"name":489,"role":89,"phone":11,"phoneExt":11,"email":11},"Tuyen Nguyen",{"facility":491,"status":67,"city":492,"state":453,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":493,"geoPoint":497,"contacts":498},"Montreal General Hospital- McGill","Montreal",{"type":74,"coordinates":494},[495,496],-73.58781,45.50884,{"lat":496,"lon":495},[499,503,505],{"name":500,"role":55,"phone":501,"phoneExt":11,"email":502},"Todd C Lee","(514) 934-1934","todd.lee@mcgill.ca",{"name":504,"role":50,"phone":11,"phoneExt":11,"email":11},"Emily Mcdonald",{"name":500,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":507,"status":67,"city":492,"state":453,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":508,"geoPoint":510,"contacts":511},"Royal Victoria Hospital- McGill",{"type":74,"coordinates":509},[495,496],{"lat":496,"lon":495},[512,513,515],{"name":500,"role":55,"phone":501,"phoneExt":11,"email":502},{"name":514,"role":50,"phone":11,"phoneExt":11,"email":11},"Emily McDonald",{"name":500,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":517,"status":67,"city":518,"state":453,"zip":11,"country":194,"countryCode":195,"cosmosGeoPoint":519,"geoPoint":523,"contacts":524},"Université de Sherbrooke","Sherbrooke",{"type":74,"coordinates":520},[521,522],-71.89908,45.40008,{"lat":522,"lon":521},[525],{"name":526,"role":55,"phone":11,"phoneExt":11,"email":11},"François Lamontagne, MD",{"facility":528,"status":67,"city":529,"state":453,"zip":530,"country":194,"countryCode":195,"cosmosGeoPoint":531,"geoPoint":535,"contacts":536},"Centre hospitalier affilié universitaire régional (CHAUR)","Trois-Rivières","G8Z 3R9",{"type":74,"coordinates":532},[533,534],-72.5477,46.34515,{"lat":534,"lon":533},[537,541],{"name":538,"role":55,"phone":539,"phoneExt":11,"email":540},"Jean-François Naud","(819) 697-3333","jean-francois.naud.med@ssss.gouv.qc.ca",{"name":538,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":543,"status":67,"city":544,"state":545,"zip":11,"country":546,"countryCode":547,"cosmosGeoPoint":548,"geoPoint":552,"contacts":553},"Universidad de La Sabana","Chía","Cundinamarca","Colombia","CO",{"type":74,"coordinates":549},[550,551],-74.05866,4.85876,{"lat":551,"lon":550},[554,558],{"name":555,"role":55,"phone":556,"phoneExt":11,"email":557},"Luis Felipe Reyes Velasco","+57 601 8615555","luis.reyes5@unisabana.edu.co",{"name":555,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":560,"status":67,"city":561,"state":562,"zip":11,"country":563,"countryCode":564,"cosmosGeoPoint":565,"geoPoint":569,"contacts":570},"Sheba Medical Center","Ramat Gan","Tel Aviv","Israel","IL",{"type":74,"coordinates":566},[567,568],34.81065,32.08227,{"lat":568,"lon":567},[571,575],{"name":572,"role":55,"phone":573,"phoneExt":11,"email":574},"Dafna Yahav","+972 3-530-3030","dafna.yahav@gmail.com",{"name":572,"role":50,"phone":11,"phoneExt":11,"email":11},{"facility":577,"status":67,"city":578,"state":578,"zip":579,"country":580,"countryCode":581,"cosmosGeoPoint":582,"geoPoint":586,"contacts":587},"Middlemore Hospital","Auckland","2025","New Zealand","NZ",{"type":74,"coordinates":583},[584,585],174.76349,-36.84853,{"lat":585,"lon":584},[588,592,595,596],{"name":589,"role":55,"phone":590,"phoneExt":11,"email":591},"Susan Morpeth, Clinical Microbiologist","+64 9 2709758","Susan.Morpeth@middlemore.co.nz",{"name":593,"role":55,"phone":590,"phoneExt":11,"email":594},"Aotearoa Clinical Trials","grants@aotearoatrials.nz",{"name":589,"role":50,"phone":11,"phoneExt":11,"email":11},{"name":597,"role":89,"phone":11,"phoneExt":11,"email":11},"Michael Trent Herdman, Specialist Registrar",{"type":50,"investigatorFullName":599,"investigatorTitle":600,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Dr. Nick Daneman","Clinician Scientist",[602,605,608,610],{"name":603,"class":604},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":606,"class":607},"Clínica Universidad de La Sabana","UNKNOWN",{"name":609,"class":607},"Universidad de La Sabana, Colombia",{"name":593,"class":6},"100557399","a-platform-trial-for-gram-negative-bloodstream-infections-100557399",false,"NCT06537609","A Platform Trial for Gram Negative Bloodstream Infections","BALANCE+: A Platform Trial for Gram Negative Bloodstream Infections","BALANCE+","PLATFORM INCLUSION CRITERIA\n\nPlatform Inclusion Criteria:\n\n* admitted to a participating hospital\n* positive blood culture with Gram negative (GN) bacterium\n\nPlatform Exclusion Criteria:\n\n* patient's goals of care are for palliation with no active treatment\n* moribund patient, not expected to survive \\> 72 hours\n* previously enrolled in the platform trial\n* not eligible for any domain at the time of screening\n\nDOMAIN SPECIFIC INCLUSION AND EXCLUSION CRITERIA\n\n1. De-escalation versus no de-escalation domain\n\n   Inclusion Criteria\n\n   \\- included in BALANCE+ platform\n\n   Exclusion Criteria\n   * receiving an empiric antibiotic regimen at the time of blood culture finalization to which the GN pathogen(s) are not sensitive\n   * arbapenem-non-susceptible\n   * no de-escalation option due to any or all of:\n\n     * antimicrobial resistance\n     * allergies\n     * medical contraindications\n     * drug-drug interaction risk\n     * other relevant reason\n   * patients with a suspected or proven polymicrobial source of infection\n   * \\> 24 hours since index blood culture susceptibility results finalization\n2. Beta-lactam versus non-beta-lactam oral\u002Fenteral treatment domain\n\n   Inclusion Criteria\n   * included in BALANCE+ platform\n   * initially treated with intravenous antibiotics, but clinical team transitioning patient to oral\u002Fenteral antibiotic within 7 days of starting treatment\n\n   Exclusion Criteria\n   * enrolled in an arm of another BALANCE+ platform domain which limits the use of oral\u002Fenteral therapy:\n   * no-de-escalation arm (patients in the no de-escalation arm cannot be randomized into this domain unless they are ready for discharge home, in which case de-escalation is allowable to oral agents at discharge)\n   * no non-beta-lactam options due to any or all of:\n\n     * resistance\n     * allergies\n     * medical contraindications\n     * drug-interaction risk\n     * other relevant reason\n   * no beta-lactam options due to any or all of:\n\n     * resistance\n     * allergies\n     * medical contraindications\n     * drug-interaction risk\n     * other relevant reason\n   * pregnancy\n   * already received \\>24 hours of oral antibiotics after index blood culture finalization\n3. Central vascular catheter replacement domain\n\n   Inclusion Criteria\n   * included in BALANCE+ platform\n   * has an indwelling central vascular catheter that was already in place within the 48-hour period before the onset of bloodstream infection (i.e. is not a new catheter placed within 48 hours of the onset of infection)\n\n   Exclusion Criteria\n   * patient has no ongoing need for a central vascular catheter\n   * patient has definite indication for central vascular catheter removal\n   * ongoing septic shock with definite\u002Fprobable line source\n\n     * concomitant S. aureus bacteremia\n     * concomitant candidemia\n   * local suppurative signs (severe redness, warmth, pain, swelling or fluctuance\u002Fcollection) necessitating catheter removal, or other clinical evidence of infected line (e.g. imaging\u002Fechocardiographic findings)\n4. Low-risk AmpC domain\n\n   Inclusion Criteria\n   * included in BALANCE+ platform\n   * positive blood culture with GN bacterium, of the following species: i. Serratia spp. ii Morganella spp. iii Providencia spp. iv Proteus spp. other than P.mirabilis\n   * organism is susceptible to ceftriaxone\n\n   Exclusion Criteria\n   * severe allergy to beta-lactams (e.g., type 4 hypersensitivity reaction or DRESS)\n   * baseline phenotypic non-susceptiblity to ceftriaxone\n   * more than 1 calendar day beyond availability of susceptibility results\n5. Follow up blood culture domain\n\nInclusion Criteria\n\n\\- included in BALANCE+ platform\n\nExclusion Criteria\n\n* patient died or discharged from hospital prior to day 4\n* blood culture already collected by the treating team at day 4±1\n* \\>5 days since index positive blood culture collection\n* definite indication for repeat blood culture testing\n\n  * concomitant S. aureus bacteremia\n  * concomitant Candidemia\n  * clinical suspicion for infective endocarditis","ALL","0 Years","130 Years",{"count":623,"type":624},2500,"ESTIMATED","INTERVENTIONAL",[627],"NA","BALANCE+ is a perpetual multiple domain randomized controlled platform trial to evaluate various treatment strategies for Gram-negative bloodstream infections (GN BSIs). Each domain addresses critical questions in the management of GN BSIs, aiming to refine treatment strategies, enhance patient outcomes, and reduce antimicrobial resistance.\n\nThe initial vanguard pilot RCT (NCT05893147) started on 29 August 2023 and has successfully completed the pilot phase on 24-Apr-2024. All patients enrolled in the vanguard phase are part of the main platform trial.",[630],"Gram-negative Bacteremia","2026-02-06",{"date":633,"type":634},"2026-02-10","ACTUAL",{"date":636,"type":634},"2024-04-24",{"date":638,"type":624},"2028-04",{"name":5,"class":6},39]