protocolSection identificationModule nctId: NCT06336824, orgStudyIdInfo id: EVOS 1.2 dated 25/10/2023, briefTitle: Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia, acronym: EVOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Clinical Research Centre, Malaysia, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Staphylococcus Aureus Bacteremia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 290, type: ESTIMATED, armsInterventionsModule interventions name: Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid, interventions name: IV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline, outcomesModule primaryOutcomes measure: Rate of SAB-relapse, secondaryOutcomes measure: Number of days of hospitalization, secondaryOutcomes measure: Rate of all-cause mortality, secondaryOutcomes measure: Rate of complications related to IV therapy, secondaryOutcomes measure: Rate of Clostridium difficile diarrhoea, secondaryOutcomes measure: Rate of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Sultanah Aminah, city: Johor Bahru, state: Johor, zip: 80100, country: Malaysia, contacts name: Wei Xuan Tuang, role: CONTACT, email: weixuan0706@gmail.com, geoPoint lat: 1.4655, lon: 103.7578, locations facility: Hospital Sultanah Bahiyah, city: Alor Setar, state: Kedah, zip: 05460, country: Malaysia, contacts name: Sharifah Baizura Syed Alwi, role: CONTACT, email: baizura1973@hotmail.my, geoPoint lat: 6.12104, lon: 100.36014, locations facility: Hospital Sultan Abdul Halim, city: Sungai Petani, state: Kedah, zip: 08000, country: Malaysia, contacts name: Noralfazita An, role: CONTACT, email: noralfazitaa@moh.gov.my, geoPoint lat: 5.647, lon: 100.48772, locations facility: Hospital Tuanku Ja'afar, city: Seremban, state: Negeri Sembilan, zip: 70300, country: Malaysia, contacts name: Tiang Koi Ng, role: CONTACT, email: tiangkoi79@yahoo.com, geoPoint lat: 2.7297, lon: 101.9381, locations facility: Hospital Pulau Pinang, city: George Town, state: Penang, zip: 10450, country: Malaysia, contacts name: Chuan Huan Chuah, role: CONTACT, email: chchuah7@yahoo.com, geoPoint lat: 5.41123, lon: 100.33543, locations facility: Hospital Seberang Jaya, city: Seberang Jaya, state: Penang, zip: 13700, country: Malaysia, contacts name: Peng Peng Ang, role: CONTACT, email: angpp2209@gmail.com, geoPoint lat: 5.39085, lon: 100.41044, locations facility: Hospital Raja Permaisuri Bainun, city: Ipoh, state: Perak, zip: 30450, country: Malaysia, contacts name: Steven Lim, role: CONTACT, email: stevenlimcl@gmail.com, geoPoint lat: 4.5841, lon: 101.0829, locations facility: Hospital Ampang, city: Ampang, state: Selangor, zip: 68000, country: Malaysia, contacts name: Suraya Hanim Abdullah Hashim, role: CONTACT, email: surayahanim.abdullahhashim@gmail.com, locations facility: Hospital Sultan Idris Shah Serdang, city: Kajang, state: Selangor, zip: 43000, country: Malaysia, contacts name: Kah Chuan Lim, role: CONTACT, email: ck7902@gmail.com, geoPoint lat: 2.99424, lon: 101.78875, locations facility: Hospital Tengku Ampuan Rahimah, city: Klang, state: Selangor, zip: 41200, country: Malaysia, contacts name: Azureen Azmel, role: CONTACT, email: aazmel@gmail.com, geoPoint lat: 3.03333, lon: 101.45, locations facility: Hospital Selayang, city: Selayang Baru Utara, state: Selangor, zip: 68100, country: Malaysia, contacts name: Anuradha P. Radhakrisnan, role: CONTACT, email: anurapr70@gmail.com, geoPoint lat: 3.2549, lon: 101.6668, locations facility: Hospital Melaka, city: Melaka, zip: 75400, country: Malaysia, contacts name: Wee Fu Gan, role: CONTACT, email: ganweefu@gmail.com, geoPoint lat: 2.196, lon: 102.2405, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-10-25, uploadDate: 2024-03-28T09:13, filename: Prot_SAP_001.pdf, size: 749936, hasResults: False