Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07148960

Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Staphylococcus Aureus Bacteremia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is hospitalized at J.W. Ruby Memorial Hospital, Berkeley Medical Center, Camden Clark Medical Center, Princeton Community Hospital, Thomas 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

Treatment and study plan

Early Dual IV Antibiotic Therapy - MRSA

Drug

Participant given IV daptomycin plus ceftaroline dosing per standard of care. Oral rifampin may be added for participants with prosthetic material.

Other names: daptomycin, ceftaroline, rifampin

Early Dual IV Antibiotic Therapy - MSSA

Drug

Participant given IV cefazolin plus ertapenem dosing per standard of care. Oral rifampin may be added for participants with prosthetic material.

Other names: cefazolin, ertapenem, rifampin

Single Agent IV Antibiotic Therapy - MRSA

Drug

Participant given one of the following IV therapies: daptomycin, vancomycin, or ceftaroline. Oral rifampin may be added for participants with prosthetic material.

Other names: daptomycin, vancomycin, ceftaroline, rifampin

Single Agent IV Antibiotic Therapy - MSSA

Drug

Participant given one of the following IV therapies: cefazolin, oxacillin, or nafcillin. Oral rifampin may be added for participants with prosthetic material.

Other names: cefazolin, oxacillin, nafcillin, rifampin

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Number of patients with cure/control

    Time frame: Up to 12 weeks post hospital discharge

    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.

  2. Time to Positivity (TTP)

    Time frame: Up to 14 days post hospital admission

    Time in hours from first set of blood culture bottle on laboratory instrument to positive culture bottle off laboratory instrument (TTP1).

  3. Sequential Time to Positivity (STTP)

    Time frame: Up to 14 days post hospital admission

    Ratio of the Time to Positivity of the second set of blood cultures divided by the first set of blood cultures (TTP2/TTP1).

  4. Length of Hospital Stay

    Time frame: Up to 12 weeks post hospital discharge

    Duration in days from hospital admission to hospital discharge.

  5. Overall Hospital Readmission

    Time frame: Up to 12 weeks post hospital discharge

    Number of participants readmitted for any reason up to 12 weeks after discharge from the hospital.

  6. Rate of Relapsed Bacteremia

    Time frame: Up to 12 weeks post hospital discharge

    Recurrence of bacteremia with the same organism one week after initial clearance.

  7. Time to First Negative Blood Culture

    Time frame: Up to 14 days post hospital admission

    Time from hospital admission to the first documented negative blood culture.

  8. Incidence of Antibiotic-Associated Side Effects and Toxicity

    Time frame: Up to 12 weeks post hospital discharge

    Occurrence of adverse events related to antibiotic therapy, including Clostridioides difficile infection, as assessed by clinical evaluation and laboratory testing.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Acronym: SABEDTIO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.