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Recruiting Phase 3 NCT06336824

Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia

Trial Parameters

Condition Staphylococcus Aureus Bacteremia
Sponsor Clinical Research Centre, Malaysia
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 290
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-28
Completion 2025-05
Interventions
Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. LinezolidIV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Blood culture positive for Staphylococcus aureus (S. aureus). 2. Received 3 to 7 days of definitive IV antimicrobial therapy, defined as: * Cloxacillin or cefazolin for methicillin-sensitive staphylococcus aureus (MSSA); Vancomycin or ceftaroline for methicillin-resistant staphylococcus aureus (MRSA). * Proven in-vitro susceptibility and adequate dosing given (as determined by the principal investigator). 3. 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. 4. Achieved defervescence, defined as sustained body temperature ≤37.5°C within 48 hours before randomization. 5. Able to provide written informed consent to participate trial. Exclusion Criteria: 1. Evidence of metastatic infection of S. aureus: for example, infective endocarditis, intraabdominal abscess, lung empyema, and osteomyelitis. Radiological investigations

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