NCT07148960

Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?

Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes? (SABEDTIO) Clinical Trial

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this open-label, pragmatic, randomized controlled clinical trial is to learn if patients with Staphylococcus aureus bacteremia (SAB) given the intervention of early dual intravenous (IV) antibiotic therapy will decrease duration of bacteremia (\< 6 days) and improve outcomes compared to single IV antibiotic therapy. The main questions this study aims to answer are: * To decrease SAB duration and improve outcomes by using early dual vs. single agent IV antibiotic therapy * To accelerate practice transformation of earlier IV to oral (PO) antibiotic transition by switching to PO antibiotic therapy once blood cultures are negative at 72 hours Participants will be asked to agree to be randomized (like flipping a coin) to receive two or one IV antibiotic(s). Once the infection has cleared, the treatment will be changed to PO antibiotics. As part of usual care, participants will have weekly lab tests for monitoring while on antibiotics, receive a telephone call to see how the participants are doing, and follow up in person or by telephone or video in Infectious Diseases (ID) Clinic. Participant participation will last 12 weeks after the participant is discharged from the hospital.

Conditions

• Staphylococcus Aureus Bacteremia

Interventions

Type	Name	Description
DRUG	Early Dual IV Antibiotic Therapy - MRSA	Participant given IV daptomycin plus ceftaroline dosing per standard of care. Oral rifampin may be added for participants with prosthetic material.
DRUG	Early Dual IV Antibiotic Therapy - MSSA	Participant given IV cefazolin plus ertapenem dosing per standard of care. Oral rifampin may be added for participants with prosthetic material.
DRUG	Single Agent IV Antibiotic Therapy - MRSA	Participant given one of the following IV therapies: daptomycin, vancomycin, or ceftaroline. Oral rifampin may be added for participants with prosthetic material.
DRUG	Single Agent IV Antibiotic Therapy - MSSA	Participant given one of the following IV therapies: cefazolin, oxacillin, or nafcillin. Oral rifampin may be added for participants with prosthetic material.

Timeline

• Start date: 2025-09-15
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-08-29
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study