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