[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100384904":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":212,"collaborators":25,"id":216,"slug":217,"hasResults":218,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":218,"sex":224,"minAge":225,"maxAge":25,"enrollmentInfo":226,"targetDuration":25,"studyType":229,"phases":230,"briefSummary":232,"conditions":233,"keywords":236,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"fullName":5,"class":6},"Hvidovre University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Shortened antibiotic treatment of 5 days",[13],"Other: Shortened antibiotic treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Standard antibiotic treatment of minimum 7 days at the discretion of treating physician",[19],"Other: Standard antibiotic treatment",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Shortened antibiotic treatment","Shortened antibiotic treatment of 5 days. Participation in the study will only affect treatment duration and will have no influence on the choice of treatment in respect to type and dose of antibiotic treatment.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard antibiotic treatment","Standard antibiotic treatment of minimum 7 days at the discretion of treating physician. Participation in the study will only affect treatment duration and will have no influence on the choice of treatment in respect to type and dose of antibiotic treatment.",[15],[31],{"name":32,"affiliation":5,"role":33},"Sandra Tingsgård, MD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+4520544094","sandra.tingsgaard@regionh.dk",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":41},"Thomas Benfield, MD DMSc","thomas.lars.benfield@regionh.dk",[43,60,73,86,96,109,122,136,149,160,173,186,199],{"facility":44,"status":45,"city":46,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University Hospital of Aalborg","NOT_YET_RECRUITING","Aalborg","9000","Denmark","DK",{"type":51,"coordinates":52},"Point",[53,54],9.9187,57.048,{"lat":54,"lon":53},[57],{"name":58,"role":36,"phone":25,"phoneExt":25,"email":59},"Henrik Nielsen, MD DMSc","henrik.nielsen@rn.dk",{"facility":61,"status":45,"city":62,"state":25,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"University Hospital of Aarhus","Aarhus","8200",{"type":51,"coordinates":65},[66,67],10.21076,56.15674,{"lat":67,"lon":66},[70],{"name":71,"role":36,"phone":25,"phoneExt":25,"email":72},"Lars Østergaard, MD DMSc","larsoest@rm.dk",{"facility":74,"status":45,"city":75,"state":25,"zip":76,"country":48,"countryCode":49,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Rigshospitalet","Copenhagen","2100",{"type":51,"coordinates":78},[79,80],12.56553,55.67594,{"lat":80,"lon":79},[83],{"name":84,"role":36,"phone":25,"phoneExt":25,"email":85},"Jan Gertoft, MD DMSc","jan.gerstoft@regionh.dk",{"facility":87,"status":88,"city":75,"state":25,"zip":89,"country":48,"countryCode":49,"cosmosGeoPoint":90,"geoPoint":92,"contacts":93},"Bispebjerg Hospital","RECRUITING","2400",{"type":51,"coordinates":91},[79,80],{"lat":80,"lon":79},[94],{"name":95,"role":36,"phone":25,"phoneExt":25,"email":25},"Jesper Andreas Knudsen, MD, PhD",{"facility":97,"status":88,"city":98,"state":25,"zip":99,"country":48,"countryCode":49,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Gentofte Hospital","Hellerup","2900",{"type":51,"coordinates":101},[102,103],12.57093,55.73204,{"lat":103,"lon":102},[106],{"name":107,"role":36,"phone":25,"phoneExt":25,"email":108},"Pernille Ravn, MD PhD","pernille.ravn.02@regionh.dk",{"facility":110,"status":88,"city":111,"state":25,"zip":112,"country":48,"countryCode":49,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Herlev Hospital","Herlev","2730",{"type":51,"coordinates":114},[115,116],12.43998,55.72366,{"lat":116,"lon":115},[119],{"name":120,"role":36,"phone":25,"phoneExt":25,"email":121},"Suzanne Lunding, MD PhD","suzanne.lunding.01@regionh.dk",{"facility":123,"status":45,"city":124,"state":25,"zip":125,"country":48,"countryCode":49,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Herning Hospital","Herning","7400",{"type":51,"coordinates":127},[128,129],8.97662,56.13615,{"lat":129,"lon":128},[132,134],{"name":133,"role":36,"phone":25,"phoneExt":25,"email":25},"Rajesh Mohey, MD PhD",{"name":25,"role":36,"phone":25,"phoneExt":25,"email":135},"rajemohe@rm.dk",{"facility":137,"status":88,"city":138,"state":25,"zip":139,"country":48,"countryCode":49,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Nordsjaellands Hospital","Hillerød","3400",{"type":51,"coordinates":141},[142,143],12.30081,55.92791,{"lat":143,"lon":142},[146],{"name":147,"role":36,"phone":25,"phoneExt":25,"email":148},"Birgitte Lindegaard Madsen, MD PhD","birgitte.lindegaard.madsen@regionh.dk",{"facility":150,"status":88,"city":151,"state":25,"zip":152,"country":48,"countryCode":49,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Hvidovre Hospital","Hvidovre","2650",{"type":51,"coordinates":154},[155,156],12.47708,55.64297,{"lat":156,"lon":155},[159],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},{"facility":161,"status":45,"city":162,"state":25,"zip":163,"country":48,"countryCode":49,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Kolding Hospital","Kolding","6000",{"type":51,"coordinates":165},[166,167],9.47216,55.4904,{"lat":167,"lon":166},[170],{"name":171,"role":36,"phone":25,"phoneExt":25,"email":172},"Janne Jensen, MD","janne.jensen@rsyd.dk",{"facility":174,"status":45,"city":175,"state":25,"zip":176,"country":48,"countryCode":49,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Odense University Hospital","Odense","5000",{"type":51,"coordinates":178},[179,180],10.38831,55.39594,{"lat":180,"lon":179},[183],{"name":184,"role":36,"phone":25,"phoneExt":25,"email":185},"Isik Johansen, MD DMSc","isik.somuncu.johansen@rsyd.dk",{"facility":187,"status":45,"city":188,"state":25,"zip":189,"country":48,"countryCode":49,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Roskilde Hospital","Roskilde","4000",{"type":51,"coordinates":191},[192,193],12.08035,55.64152,{"lat":193,"lon":192},[196],{"name":197,"role":36,"phone":25,"phoneExt":25,"email":198},"Lothar Wiese, MD PhD","low@regionsjaelland.dk",{"facility":200,"status":45,"city":201,"state":25,"zip":202,"country":48,"countryCode":49,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Regionshospitalet Silkeborg","Silkeborg","8600",{"type":51,"coordinates":204},[205,206],9.54508,56.1697,{"lat":206,"lon":205},[209],{"name":210,"role":36,"phone":25,"phoneExt":25,"email":211},"Britta Tarp, MD PhD","brittarp@rm.dk",{"type":213,"investigatorFullName":214,"investigatorTitle":215,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Thomas Benfield","Clinical Professor","100384904","phase-4-shortened-antibiotic-treatment-of-5-days-in-gram-negative-bacteremia-100384904",false,"NCT04291768","Shortened Antibiotic Treatment of 5 Days in Gram-negative Bacteremia","Short Course Antibiotic Treatment of Gram-negative Bacteremia: A Multicenter, Randomized, Non-blinded, Non-inferiority Interventional Study","GNB5","Inclusion Criteria:\n\n* Age \\>18 years\n* Blood culture positive for Gram-negative bacteria\n* Evidence of urinary tract source of infection (positive urine culture or at least one clinical symptom compatible with urinary tract infection)\n* Antibiotic treatment with antimicrobial activity to Gram-negative bacteria administrated within 12 hours of first blood culture\n* Temperature \\\u003C37.8°C at randomization\n* Clinically stabile at randomization (systolic blood pressure \\> 90 mm Hg, heart rate \\\u003C100 beats\u002Fmin., respiratory rate \\\u003C24\u002Fminute, peripheral oxygen saturation \\> 90 %)\n* Oral and written informed consent\n\nExclusion Criteria:\n\n* Antibiotic treatment (\\>2 day) with antimicrobial activity to Gram-negative bacteria within 14 days of inclusion\n* Gram-negative bacteremia within 30 days of blood culture\n* Immunosuppression (Untreated HIV-infection, Neutropenia (absolute neutrophil count \\\u003C 1.0 x 109\u002Fl), Untreated terminal cancer, Receiving immunosuppressive agents (ATC-code L04A), Corticosteroid treatment (≥20 mg\u002Fday prednisone or the equivalent for \\>14 days) within the last 30 days, Chemotherapy within the last 30 days, Immunosuppressed after solid organ transplantation, Asplenia)\n* Polymicrobial growth in blood culture\n* Bacteremia with non-fermenting Gram-negative bacteria (Acinetobacter spp, Burkholderia spp, Pseudomonas spp), Brucella spp, or Fusobacterium spp\n* Failure to remove source of infection within 72 hours of first blood culture (e.g. change of catheter á demeure)\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":227,"type":228},380,"ESTIMATED","INTERVENTIONAL",[231],"PHASE4","GNB5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic for patients hospitalized with a Gram negative bacteremia with a urinary tract source of infection (GNB).\n\nFive days after initiation of antimicrobial therapy for GNB, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician.\n\nThe primary outcome is 90-day survival without clinical or microbiological failure to treatment, which will be tested with a non inferiority margin of 10%.",[234,235],"Gram-negative Bacteremia","Urinary Tract Infection Bacterial",[237,238,22,239],"Gram-negative bacteremia","Urinary tract infection","Bacterial infection","2023-02-06",{"date":242,"type":243},"2023-02-08","ACTUAL",{"date":245,"type":243},"2020-03-11",{"date":247,"type":228},"2026-10-01",{"name":214,"class":6},13]