[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454575":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":41,"locations":51,"responsibleParty":66,"collaborators":68,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":45,"enrollmentInfo":133,"targetDuration":45,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":53,"whyStopped":45,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Tan Tock Seng Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early switch to oral antibiotic therapy","EXPERIMENTAL","The oral antibiotic options are fluoroquinolones (most commonly, ciprofloxacin) or trimethoprim-sulfamethoxazole. The recommended doses for patients with normal renal function would be ciprofloxacin 750 mg twice daily (if body weight ≥70 kg) or ciprofloxacin 500 mg twice daily (if body weight \\\u003C70 kg) or trimethoprim-sulfamethoxazole 5 mg\u002Fkg (for trimethoprim component) every 12 hourly or trimethoprim-sulfamethoxazole (160 mg \u002F 800 mg; double strength) two tablets twice daily. Doses may be adjusted in the setting of renal dysfunction. The recommended treatment duration by the study team is 7 days of active antibiotics (including empiric therapy), although treatment regimen may be longer than 7 days due to regimen extension or requirement for prolonged regimen as clinically indicated.",[13],"Drug: Oral fluoroquinolones (most commonly, ciprofloxacin) or oral trimethoprim-sulfamethoxazole",{"label":15,"type":16,"description":17,"interventionNames":18},"Continuing intravenous antibiotic therapy","ACTIVE_COMPARATOR","The intravenous antibiotics to be administered will be determined by the treating doctor according to what would be considered standard of care in the hospital site. Commonly used intravenous antibiotics (and doses) for treatment of Gram-negative bacteraemia include ceftriaxone 2 g daily or cefazolin 2 g three times daily. The recommended treatment duration by the study team is 7 days of active antibiotics (including empiric therapy), although treatment regimen may be longer than 7 days due to regimen extension or requirement for prolonged regimen as clinically indicated.",[19],"Drug: Standard of care intravenous antibiotics (e.g. ceftriaxone, cefazolin)",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Oral fluoroquinolones (most commonly, ciprofloxacin) or oral trimethoprim-sulfamethoxazole","Clinically stable \u002F non-critically ill inpatients with uncomplicated Gram-negative bacteraemia randomised to the intervention arm will immediately be switched to oral antibiotics (within 72 hours from index blood culture collection)",[9],[27,28,29],"Ciprofloxacin","Bactrim","Co-Trimoxazole",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Standard of care intravenous antibiotics (e.g. ceftriaxone, cefazolin)","Clinically stable \u002F non-critically ill inpatients with uncomplicated Gram-negative bacteraemia randomised to the standard arm will continue to receive an active intravenous antibiotic therapy for at least another 24 hours post-randomisation",[15],[35,36],"Rocephin","Kefzol",[38],{"name":39,"affiliation":5,"role":40},"David Lye, MBBS","PRINCIPAL_INVESTIGATOR",[42,47],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","(65) 63577457",null,"david.lye@nhghealth.com.sg",{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},"I. Russel Lee, PhD","(65) 65115060","lee.mc.ivor.russel@nhghealth.com.sg",[52],{"facility":5,"status":53,"city":54,"state":54,"zip":55,"country":54,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Singapore","308433","SG",{"type":58,"coordinates":59},"Point",[60,61],103.85007,1.28967,{"lat":61,"lon":60},[64,65],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},{"name":48,"role":43,"phone":49,"phoneExt":45,"email":50},{"type":67,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[69,71,73,75,77,79,81,84,87,89,91,93,95,97,99,101,103,105,107,109,111,113,115,117,119,121],{"name":70,"class":6},"National University Hospital, Singapore",{"name":72,"class":6},"Singapore General Hospital",{"name":74,"class":6},"Changi General Hospital",{"name":76,"class":6},"Sengkang General Hospital",{"name":78,"class":6},"Ng Teng Fong General Hospital",{"name":80,"class":6},"University of Malaya",{"name":82,"class":83},"KPJ Ampang Puteri Specialist Hospital","OTHER_GOV",{"name":85,"class":86},"Hospital Sungai Buloh, Selangor","UNKNOWN",{"name":88,"class":6},"Universiti Kebangsaan Malaysia Medical Centre",{"name":90,"class":6},"Taichung Veterans General Hospital",{"name":92,"class":6},"Melbourne Health",{"name":94,"class":83},"Gold Coast Hospital and Health Service",{"name":96,"class":6},"Princess Alexandra Hospital, Brisbane, Australia",{"name":98,"class":6},"Istanbul Medipol University Hospital",{"name":100,"class":6},"Rambam Health Care Campus",{"name":102,"class":83},"Sheba Medical Center",{"name":104,"class":86},"University Hospital of Pisa",{"name":106,"class":6},"IRCCS San Raffaele",{"name":108,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"name":110,"class":6},"Seoul National University Bundang Hospital",{"name":112,"class":6},"Samsung Medical Center",{"name":114,"class":6},"American University of Beirut Medical Center",{"name":116,"class":6},"University Hospital of Patras",{"name":118,"class":6},"Hospital del Mar",{"name":120,"class":6},"Singapore Clinical Research Institute",{"name":122,"class":6},"Consorzio per Valutazioni Biologiche e Farmacologiche","100454575","phase-4-early-oral-switch-for-uncomplicated-gram-negative-bacteraemia-100454575",false,"NCT05199324","Early Oral Switch for Uncomplicated Gram-negative Bacteraemia","Early Oral Step-down Antibiotic Therapy Versus Continuing Intravenous Therapy for Uncomplicated Gram-negative Bacteraemia (the INVEST Trial)","INVEST","Inclusion Criteria:\n\n1. One or more set(s) of blood cultures positive for Gram-negative bacteria (GNB) associated with evidence of infection\n2. Able to be randomised within 72 hours of index blood culture collection\n3. Age ≥18 years (≥21 in Singapore)\n4. Latest Pitt bacteraemia score \\\u003C4\n5. Patient or legal representative is able to provide informed consent\n\nExclusion Criteria:\n\n1. Established uncontrolled focus of infection, including but not limited to:\n\n   * Undrained abdominal abscess, deep seated intra-abdominal infection and other unresolved abdominal sources requiring surgical intervention\n   * Central nervous system abscess (patients with focal neurology should have cranial CT prior to enrolment)\n   * Undrained moderate-to-severe hydronephrosis\n2. Complicated infections, including but not limited to:\n\n   * Necrotising fasciitis\n   * Empyema\n   * Central nervous system infections and meningitis\n   * Endocarditis \u002F endovascular infections\n3. Septic shock as defined by systolic blood pressure \\\u003C90 or mean arterial pressure \\\u003C70 mmHg despite adequate fluid resuscitation or need for inotropic\u002Fvasopressor support\n4. Polymicrobial bacteraemia involving Gram-positive pathogens or anaerobes (defined as either growth of 2 or more different microorganism species in the same blood culture, or growth of different species in 2 or more separate blood cultures within the same episode \\[\\\u003C48 hours\\] and with clinical or microbiological evidence of the same source)\n5. Bacteraemia is due to a vascular catheter or intravascular materials (e.g. pacing wire, vascular graft) that cannot be removed\n6. Specific Gram-negative pathogens that cannot be effectively treated with fluoroquinolones or trimethoprim-sulfamethoxazole, including but not limited to, Burkholderia spp. and Brucella spp.\n7. Index GNB with resistance to fluoroquinolones AND trimethoprim-sulfamethoxazole\n8. Hypersensitivity to fluoroquinolones AND sulphur drugs as defined by history of rash, urticaria, angioedema, bronchospasm, circulatory collapse or significant adverse reaction following prior administration\n9. Unable to consume or absorb oral medications for any reason or unsuitable for ongoing IV therapy (e.g. no intravenous access)\n10. Severely immunocompromised in the opinion of the treating doctor, including but not limited to, medical conditions such as:\n\n    * Active leukaemia or lymphoma\n    * Aplastic anaemia\n    * Bone marrow transplant within two years of transplantation or transplants of longer duration still on immunosuppressive drugs or with graft-versus-host disease\n    * Congenital immunodeficiency\n    * HIV\u002FAIDS with CD4 lymphocyte count \\\u003C200\n    * Neutropenia or expected post-chemotherapy neutropenia within 14 days from the time of screening, defined as absolute neutrophil count \\\u003C 500 cells\u002FμL\n11. Women who are known to be pregnant or breast-feeding\n12. Treatment is not with intent to cure the infection (i.e. palliative care)\n13. Unable to collect patient's follow-up data for at least 30 days post-randomisation for any reason\n14. Treating doctor deems enrolment into the trial is not in the best interest of the patient\n15. Previous enrolment in this trial","ALL","18 Years",{"count":134,"type":135},720,"ESTIMATED","INTERVENTIONAL",[138],"PHASE4","Current management of uncomplicated Gram-negative bacteraemia entails prolong intravenous (IV) antibiotic therapy with limited evidence to guide oral conversion. This trial aim to evaluate the clinical efficacy and economic impact of early switch to oral antibiotics (within 72 hours from index blood culture collection) versus continuing standard of care IV therapy (for at least another 24 hours post-randomisation) for clinically stable \u002F non-critically ill inpatients with uncomplicated Gram-negative bacteraemia.",[141],"Gram-negative Bacteraemia",[143,144,145,146,147,148,149],"uncomplicated bacteraemia","gram-negative bacteria","early oral switch","antibiotics","fluoroquinolones","ciprofloxacin","trimethoprim-sulfamethoxazole","2026-04-13",{"date":152,"type":153},"2026-04-16","ACTUAL",{"date":155,"type":153},"2022-06-03",{"date":157,"type":135},"2026-07",{"name":5,"class":6},1]