Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes? (SABEDTIO) Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Enrolling By Invitation
- Sponsor
- West Virginia University
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Percentage of participants with prolonged bacteremia (≥ 6 days)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient is hospitalized at J.W. Ruby Memorial Hospital, Berkeley Medical Center, Camden Clark Medical Center, Princeton Community Hospital, United Hospital Center, or Wheeling Hospital
- •The patient has been identified to have Staphylococcus aureus bacteremia
- •The patient is able to participate in lab monitoring and in-person or telemedicine ID Clinic follow-up
Exclusion Criteria
- •The patient or an appointed medical decision maker is unable to give informed consent
- •The patient is a prisoner, pregnant, and/or mentally handicapped
- •The patient is determined unsafe for enrollment at the primary team's discretion
Arms & Interventions
Early Dual IV Antibiotic Therapy
Once type of Staphylococcus aureus bacteremia (MRSA vs. MSSA) is determined the following IV antibiotics will be given:
- MRSA - daptomycin plus ceftaroline;
- MSSA - cefazolin plus ertapenem;
- MRSA or MSSA - rifampin PO may be added for patients with prosthetic material
Intervention: Early Dual IV Antibiotic Therapy - MRSA (Drug)
Early Dual IV Antibiotic Therapy
Once type of Staphylococcus aureus bacteremia (MRSA vs. MSSA) is determined the following IV antibiotics will be given:
- MRSA - daptomycin plus ceftaroline;
- MSSA - cefazolin plus ertapenem;
- MRSA or MSSA - rifampin PO may be added for patients with prosthetic material
Intervention: Early Dual IV Antibiotic Therapy - MSSA (Drug)
Single Agent IV Antibiotic Therapy
Once type of Staphylococcus aureus bacteremia (MRSA vs. MSSA) is determined the following IV antibiotics will be given:
- MRSA - daptomycin, vancomycin, or ceftaroline;
- MSSA - cefazolin, oxacillin, or nafcillin;
- MRSA or MSSA - rifampin PO may be added for patients with prosthetic material
Intervention: Single Agent IV Antibiotic Therapy - MRSA (Drug)
Single Agent IV Antibiotic Therapy
Once type of Staphylococcus aureus bacteremia (MRSA vs. MSSA) is determined the following IV antibiotics will be given:
- MRSA - daptomycin, vancomycin, or ceftaroline;
- MSSA - cefazolin, oxacillin, or nafcillin;
- MRSA or MSSA - rifampin PO may be added for patients with prosthetic material
Intervention: Single Agent IV Antibiotic Therapy - MSSA (Drug)
Outcomes
Primary Outcomes
Percentage of participants with prolonged bacteremia (≥ 6 days)
Time Frame: Up to 12 weeks post hospital discharge
Percentage of participants with prolonged bacteremia (≥ 6 days) up to 12 weeks post hospital discharge.
Seeding of a New Site - Incidence
Time Frame: Up to 12 weeks post hospital discharge
Incidence of new infection of heart valve, joint, or spine up to 12 weeks post hospital discharge.
All-Cause Mortality
Time Frame: Up to 12 weeks post hospital discharge
Number of participants who died from any cause up to 12 weeks post hospital discharge.
Secondary Outcomes
- Number of patients with cure/control(Up to 12 weeks post hospital discharge)
- Time to Positivity (TTP)(Up to 14 days post hospital admission)
- Sequential Time to Positivity (STTP)(Up to 14 days post hospital admission)
- Number of patients with cure/control(Up to 12 weeks post hospital discharge)
- Time to Positivity (TTP)(Up to 14 days post hospital admission)
- Sequential Time to Positivity (STTP)(Up to 14 days post hospital admission)
- Length of Hospital Stay(Up to 12 weeks post hospital discharge)
- Overall Hospital Readmission(Up to 12 weeks post hospital discharge)
- Rate of Relapsed Bacteremia(Up to 12 weeks post hospital discharge)
- Time to First Negative Blood Culture(Up to 14 days post hospital admission)
- Incidence of Antibiotic-Associated Side Effects and Toxicity(Up to 12 weeks post hospital discharge)
Investigators
Joy J. Juskowich, MD
Assistant Professor and COpAT Medical Director
West Virginia University