[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541973":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":40,"locations":50,"responsibleParty":211,"collaborators":39,"id":216,"slug":217,"hasResults":218,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":218,"sex":224,"minAge":225,"maxAge":39,"enrollmentInfo":226,"targetDuration":39,"studyType":229,"phases":230,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":53,"whyStopped":39,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":248},{"fullName":5,"class":6},"Clinical Research Centre, Malaysia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Oral Switch Therapy (EOS)","EXPERIMENTAL","Patients will switch from IV therapy to oral antibiotics for 7 to 11 days to achieve a total 14 days of definitive antimicrobial therapy for SAB.\n\nFirst choice oral antibiotics for MSSA and MRSA: Tab. Trimethoprim-sulfamethoxazole (TMP 10mg\u002Fkg\u002Fday)\n\nAlternative oral antibiotics for MSSA: Tab. Clindamycin 600mg TDS, Tab. Cephalexin 1gm QID, Tab Linezolid 600mg BD\n\nAlternative oral antibiotics for MRSA: Tab. Linezolid 600mg BD",[13],"Drug: Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard IV therapy (SIV)","ACTIVE_COMPARATOR","Patients will continue with IV therapy for 7 to 11 days to achieve a total 14 days of definitive antimicrobial therapy for SAB.\n\nFirst choice IV antibiotics for MSSA: IV Cloxacillin 2g every 4 or 6 hours\n\nAlternative IV antibiotics for MSSA: IV Cefazolin 2g TDS\n\nFirst choice IV antibiotics for MRSA: IV Vancomycin 15-20mg\u002Fkg BD\n\nAlternative IV antibiotics for MRSA: IV Ceftaroline 600mg TDS",[19],"Drug: IV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline",[21,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid","The choice of study drug will depend on the susceptibility of the respective isolate, expected drug interactions, contraindications, and expected side effects.\n\nInvestigators will assess whether the \"first-choice\" regimen can be given and then consider the alternative regimen. The antibiotics can be switched from first choice to the respective alternative medications during the intervention period if clinically necessary. The route of administration must be maintained according to the randomized group.",[9],[27,28,29,30],"Bactrim","Dalacin","Ospexin","Zyvox",{"type":22,"name":32,"description":24,"armGroupLabels":33,"otherNames":34},"IV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline",[15],[35,36,37,38],"Cloxacillin Sodium","Cefazolin Sandoz","Vancotex","Zinforo",null,[41,46],{"name":42,"role":43,"phone":44,"phoneExt":39,"email":45},"Steven Lim, MBBS, MRCP","CONTACT","+60133620081","stevenlimcl@gmail.com",{"name":47,"role":43,"phone":48,"phoneExt":39,"email":49},"Josephine P Durai, MBBS","+6052085146","joeyukijo.28@gmai.com",[51,69,83,96,110,123,137,150,159,172,185,198],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Hospital Sultanah Aminah","RECRUITING","Johor Bahru","Johor","80100","Malaysia","MY",{"type":60,"coordinates":61},"Point",[62,63],103.7578,1.4655,{"lat":63,"lon":62},[66],{"name":67,"role":43,"phone":39,"phoneExt":39,"email":68},"Wei Xuan Tuang","weixuan0706@gmail.com",{"facility":70,"status":53,"city":71,"state":72,"zip":73,"country":57,"countryCode":58,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Hospital Sultanah Bahiyah","Alor Star","Kedah","05460",{"type":60,"coordinates":75},[76,77],100.36014,6.12104,{"lat":77,"lon":76},[80],{"name":81,"role":43,"phone":39,"phoneExt":39,"email":82},"Sharifah Baizura Syed Alwi","baizura1973@hotmail.my",{"facility":84,"status":53,"city":85,"state":72,"zip":86,"country":57,"countryCode":58,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Hospital Sultan Abdul Halim","Sungai Petani","08000",{"type":60,"coordinates":88},[89,90],100.48772,5.647,{"lat":90,"lon":89},[93],{"name":94,"role":43,"phone":39,"phoneExt":39,"email":95},"Noralfazita An","noralfazitaa@moh.gov.my",{"facility":97,"status":53,"city":98,"state":99,"zip":100,"country":57,"countryCode":58,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Hospital Tuanku Ja'afar","Seremban","Negeri Sembilan","70300",{"type":60,"coordinates":102},[103,104],101.9381,2.7297,{"lat":104,"lon":103},[107],{"name":108,"role":43,"phone":39,"phoneExt":39,"email":109},"Tiang Koi Ng","tiangkoi79@yahoo.com",{"facility":111,"status":53,"city":112,"state":113,"zip":114,"country":57,"countryCode":58,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Hospital Raja Permaisuri Bainun","Ipoh","Perak","30450",{"type":60,"coordinates":116},[117,118],101.0829,4.5841,{"lat":118,"lon":117},[121],{"name":122,"role":43,"phone":39,"phoneExt":39,"email":45},"Steven Lim",{"facility":124,"status":53,"city":125,"state":126,"zip":127,"country":57,"countryCode":58,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Hospital Pulau Pinang","George Town","Pulau Pinang","10450",{"type":60,"coordinates":129},[130,131],100.33543,5.41123,{"lat":131,"lon":130},[134],{"name":135,"role":43,"phone":39,"phoneExt":39,"email":136},"Chuan Huan Chuah","chchuah7@yahoo.com",{"facility":138,"status":53,"city":139,"state":126,"zip":140,"country":57,"countryCode":58,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hospital Seberang Jaya","Seberang Jaya","13700",{"type":60,"coordinates":142},[143,144],100.41044,5.39085,{"lat":144,"lon":143},[147],{"name":148,"role":43,"phone":39,"phoneExt":39,"email":149},"Peng Peng Ang","angpp2209@gmail.com",{"facility":151,"status":53,"city":152,"state":153,"zip":154,"country":57,"countryCode":58,"cosmosGeoPoint":39,"geoPoint":39,"contacts":155},"Hospital Ampang","Ampang","Selangor","68000",[156],{"name":157,"role":43,"phone":39,"phoneExt":39,"email":158},"Suraya Hanim Abdullah Hashim","surayahanim.abdullahhashim@gmail.com",{"facility":160,"status":53,"city":161,"state":153,"zip":162,"country":57,"countryCode":58,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Hospital Sultan Idris Shah Serdang","Kajang","43000",{"type":60,"coordinates":164},[165,166],101.78875,2.99424,{"lat":166,"lon":165},[169],{"name":170,"role":43,"phone":39,"phoneExt":39,"email":171},"Kah Chuan Lim","ck7902@gmail.com",{"facility":173,"status":53,"city":174,"state":153,"zip":175,"country":57,"countryCode":58,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Hospital Tengku Ampuan Rahimah","Klang","41200",{"type":60,"coordinates":177},[178,179],101.44333,3.03667,{"lat":179,"lon":178},[182],{"name":183,"role":43,"phone":39,"phoneExt":39,"email":184},"Azureen Azmel","aazmel@gmail.com",{"facility":186,"status":53,"city":187,"state":153,"zip":188,"country":57,"countryCode":58,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Hospital Selayang","Selayang Baru Utara","68100",{"type":60,"coordinates":190},[191,192],101.6668,3.2549,{"lat":192,"lon":191},[195],{"name":196,"role":43,"phone":39,"phoneExt":39,"email":197},"Anuradha P. Radhakrisnan","anurapr70@gmail.com",{"facility":199,"status":53,"city":200,"state":39,"zip":201,"country":57,"countryCode":58,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Hospital Melaka","Malacca","75400",{"type":60,"coordinates":203},[204,205],102.2405,2.196,{"lat":205,"lon":204},[208],{"name":209,"role":43,"phone":39,"phoneExt":39,"email":210},"Wee Fu Gan","ganweefu@gmail.com",{"type":212,"investigatorFullName":213,"investigatorTitle":214,"investigatorAffiliation":215,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Steven Lim Chee Loon","Infectious Diseases Physician","Ministry of Health, Malaysia","100541973","phase-3-early-intravenous-to-oral-antibiotic-switch-in-uncomplicated-staphylococcus-aureus-bacteraemia-100541973",false,"NCT06336824","Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia","Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia: The EVOS Randomized Controlled Trial","EVOS","Inclusion Criteria:\n\n1. Blood culture positive for Staphylococcus aureus (S. aureus).\n2. Received 3 to 7 days of definitive IV antimicrobial therapy, defined as:\n\n   * Cloxacillin or cefazolin for methicillin-sensitive staphylococcus aureus (MSSA); Vancomycin or ceftaroline for methicillin-resistant staphylococcus aureus (MRSA).\n   * Proven in-vitro susceptibility and adequate dosing given (as determined by the principal investigator).\n3. Achieved clearance of bacteraemia, defined as at least one documented latest negative follow-up blood culture obtained within 72 hours after the initiation of definitive IV antimicrobial therapy.\n4. Achieved defervescence, defined as sustained body temperature ≤37.5°C within 48 hours before randomization.\n5. Able to provide written informed consent to participate trial.\n\nExclusion Criteria:\n\n1. Evidence of metastatic infection of S. aureus: for example, infective endocarditis, intraabdominal abscess, lung empyema, and osteomyelitis. Radiological investigations such as chest X-ray, ultrasound, echocardiogram, and CT scan are not mandatory prior to enrolment, but should be done at the discretion of the treating physician if clinically indicated.\n2. Septic shock, defined as hypotension requiring vasopressors to maintain MAP ≥65 mmHg despite adequate volume resuscitation.\n3. Received more than 5 days of non-study antibiotics as empirical therapy prior to enrolment.\n4. Polymicrobial bloodstream infection, defined as isolation of pathogens other than S. aureus from a blood culture obtained prior to randomization. Common skin contaminants such as coagulase-negative staphylococci, Bacillus spp., and diphtheroid will not be considered to represent polymicrobial infection.\n5. Known history of S. aureus infection within the past 3 months.\n6. Inability to tolerate oral therapy or poor absorption of oral medications, or not suitable for ongoing IV therapy (for example, difficult intravenous access)\n7. No options of oral antibiotic available for patient due to:\n\n   * In vitro resistance of S. aureus to all oral study drugs.\n   * Known contraindications to receive the active oral study drugs. For example, hypersensitivity reaction to trimethoprim-sulfamethoxazole, thrombocytopenia secondary to linezolid etc.\n   * Non-availability of oral study drugs at the study sites.\n8. Patient is concomitantly receiving oral antibiotics which are active against S. aureus. For example, trimethoprim-sulfamethoxazole for Pneumocystis jirovecii pneumonia prophylaxis.\n9. Presence of a non-removable foreign body such as prosthetic heart valve, vascular graft, pacemaker, automated implantable cardioverter-defibrillator, ventriculoperitoneal shunt, prosthetic joint, and fracture fixation implant\n10. Failure or inability to remove intravascular catheter that is present when first positive blood culture was drawn.\n11. Known comorbidity that increased the risk of complicated infections:\n\n    * End-stage renal disease\n    * Severe liver disease (Child-Pugh class C)\n    * Severe immunodeficiency:\n\n      * HIV-positive patients with CD4\\\u003C200 cells\u002FuL or AIDS\n      * primary immunodeficiency disorders\n      * high-dose steroid therapy (\\>1 mg\u002Fkg prednisone or equivalent doses given for \\> 4 weeks or planned during intervention)\n      * immunosuppressive therapy\n      * neutropenia (\\\u003C500 neutrophils\u002Fμl) at randomization or neutropenia expected during intervention phase due to immunosuppressive treatment\n      * solid organ or hematopoietic stem cell transplantation within the past 6 months or planned during treatment period\n\n13.Short life expectancy \\\u003C 3 months\n\n14.Pregnancy (for women of childbearing potential)","ALL","18 Years",{"count":227,"type":228},290,"ESTIMATED","INTERVENTIONAL",[231],"PHASE3","The Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus aureus Bacteraemia (EVOS) study is a multicentre, randomized, open-label, parallel group, phase 3, non-inferiority trial of early intravenous to oral antibiotic switch in comparison with standard intravenous antibiotic regime among patients with uncomplicated Staphylococcus aureus bacteraemia (SAB). The study is based on the hypothesis that an early switch from IV to oral antimicrobial therapy is non-inferior and safe compared to conventional minimum 14-day course of IV therapy in patients with low-risk uncomplicated SAB.",[234],"Staphylococcus Aureus Bacteremia",[236,237,238],"bacteremia","oral antibiotics","Staphylococcus aureus","2024-07-02",{"date":241,"type":242},"2024-07-05","ACTUAL",{"date":244,"type":242},"2024-06-28",{"date":246,"type":228},"2025-06",{"name":5,"class":6},12]