Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?

Not Applicable

Not yet recruiting

• Conditions: Staphylococcus Aureus Bacteremia
• Interventions: Drug: Early Dual IV Antibiotic Therapy - MRSA; Drug: Single Agent IV Antibiotic Therapy - MRSA; Drug: Early Dual IV Antibiotic Therapy - MSSA; Drug: Single Agent IV Antibiotic Therapy - MSSA

• Registration Number: NCT07148960
• Lead Sponsor: West Virginia University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-22
• Study First Submitted QC: 2025-08-22
• Last Update Submitted: 2025-08-22
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-09-01
• Primary Completion: 2027-07
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Dual IV Antibiotic Therapy	Early Dual IV Antibiotic Therapy - MRSA	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
Early Dual IV Antibiotic Therapy	Early Dual IV Antibiotic Therapy - MSSA	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
Single Agent IV Antibiotic Therapy	Single Agent IV Antibiotic Therapy - MRSA	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
Single Agent IV Antibiotic Therapy	Single Agent IV Antibiotic Therapy - MSSA	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

Primary Outcome Measures

Name	Time	Method
Percentage of participants with prolonged bacteremia (≥ 6 days)	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	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	Up to 12 weeks post hospital discharge	Number of participants who died from any cause up to 12 weeks post hospital discharge.

Secondary Outcome Measures

Name	Time	Method
Number of patients with cure/control	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.
Time to Positivity (TTP)	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).
Sequential Time to Positivity (STTP)	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).
Length of Hospital Stay	Up to 12 weeks post hospital discharge	Duration in days from hospital admission to hospital discharge.
Overall Hospital Readmission	Up to 12 weeks post hospital discharge	Number of participants readmitted for any reason up to 12 weeks after discharge from the hospital.
Rate of Relapsed Bacteremia	Up to 12 weeks post hospital discharge	Recurrence of bacteremia with the same organism one week after initial clearance.
Time to First Negative Blood Culture	Up to 14 days post hospital admission	Time from hospital admission to the first documented negative blood culture.
Incidence of Antibiotic-Associated Side Effects and Toxicity	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.

Trial Locations

Locations (1)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States