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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Participant given IV daptomycin plus ceftaroline dosing per standard of care. Oral rifampin may be added for participants with prosthetic material.
Participant given IV cefazolin plus ertapenem dosing per standard of care. Oral rifampin may be added for participants with prosthetic material.
Participant given one of the following IV therapies: daptomycin, vancomycin, or ceftaroline. Oral rifampin may be added for participants with prosthetic material.
Participant given one of the following IV therapies: cefazolin, oxacillin, or nafcillin. Oral rifampin may be added for participants with prosthetic material.
West Virginia University
Morgantown, West Virginia, United States
Percentage of participants with prolonged bacteremia (≥ 6 days)
Percentage of participants with prolonged bacteremia (≥ 6 days) up to 12 weeks post hospital discharge.
Time frame: Up to 12 weeks post hospital discharge
Seeding of a New Site - Incidence
Incidence of new infection of heart valve, joint, or spine up to 12 weeks post hospital discharge.
Time frame: Up to 12 weeks post hospital discharge
All-Cause Mortality
Number of participants who died from any cause up to 12 weeks post hospital discharge.
Time frame: Up to 12 weeks post hospital discharge
Number of patients with cure/control
Number of patients with cure/control using clinical (resolution of infection - e.g., wound healed) and laboratory (improvement in inflammatory markers - e.g., CRP normalization) parameters.
Time frame: Up to 12 weeks post hospital discharge
Time to Positivity (TTP)
Time in hours from first set of blood culture bottle on laboratory instrument to positive culture bottle off laboratory instrument (TTP1).
Time frame: Up to 14 days post hospital admission
Sequential Time to Positivity (STTP)
Ratio of the Time to Positivity of the second set of blood cultures divided by the first set of blood cultures (TTP2/TTP1).
Time frame: Up to 14 days post hospital admission
Length of Hospital Stay
Duration in days from hospital admission to hospital discharge.
Time frame: Up to 12 weeks post hospital discharge
Overall Hospital Readmission
Number of participants readmitted for any reason up to 12 weeks after discharge from the hospital.
Time frame: Up to 12 weeks post hospital discharge
Rate of Relapsed Bacteremia
Recurrence of bacteremia with the same organism one week after initial clearance.
Time frame: Up to 12 weeks post hospital discharge
Time to First Negative Blood Culture
Time from hospital admission to the first documented negative blood culture.
Time frame: Up to 14 days post hospital admission
Incidence of Antibiotic-Associated Side Effects and Toxicity
Occurrence of adverse events related to antibiotic therapy, including Clostridioides difficile infection, as assessed by clinical evaluation and laboratory testing.
Time frame: Up to 12 weeks post hospital discharge
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