Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia: The EVOS Randomized Controlled Trial
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Blood culture positive for Staphylococcus aureus (S. aureus).
• 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).
• 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.
• Achieved defervescence, defined as sustained body temperature ≤37.5°C within 48 hours before randomization.
• Able to provide written informed consent to participate trial.
Locations
Other Locations
Malaysia
Hospital Sultanah Bahiyah
RECRUITING
Alor Star
Hospital Ampang
RECRUITING
Ampang
Hospital Pulau Pinang
RECRUITING
George Town
Hospital Raja Permaisuri Bainun
RECRUITING
Ipoh
Hospital Sultanah Aminah
RECRUITING
Johor Bahru
Hospital Sultan Idris Shah Serdang
RECRUITING
Kajang
Hospital Tengku Ampuan Rahimah
RECRUITING
Klang
Hospital Melaka
RECRUITING
Malacca
Hospital Seberang Jaya
RECRUITING
Seberang Jaya
Hospital Selayang
RECRUITING
Selayang Baru Utara
Hospital Tuanku Ja'afar
RECRUITING
Seremban
Hospital Sultan Abdul Halim
RECRUITING
Sungai Petani
Contact Information
Primary
Steven Lim, MBBS, MRCP
stevenlimcl@gmail.com
+60133620081
Backup
Josephine P Durai, MBBS
joeyukijo.28@gmai.com
+6052085146
Time Frame
Start Date:2024-06-28
Estimated Completion Date:2025-06
Participants
Target number of participants:290
Treatments
Experimental: Early Oral Switch Therapy (EOS)
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.~First choice oral antibiotics for MSSA and MRSA: Tab. Trimethoprim-sulfamethoxazole (TMP 10mg/kg/day)~Alternative oral antibiotics for MSSA: Tab. Clindamycin 600mg TDS, Tab. Cephalexin 1gm QID, Tab Linezolid 600mg BD~Alternative oral antibiotics for MRSA: Tab. Linezolid 600mg BD
Active_comparator: Standard IV therapy (SIV)
Patients will continue with IV therapy for 7 to 11 days to achieve a total 14 days of definitive antimicrobial therapy for SAB.~First choice IV antibiotics for MSSA: IV Cloxacillin 2g every 4 or 6 hours~Alternative IV antibiotics for MSSA: IV Cefazolin 2g TDS~First choice IV antibiotics for MRSA: IV Vancomycin 15-20mg/kg BD~Alternative IV antibiotics for MRSA: IV Ceftaroline 600mg TDS