Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?

NCT07148960 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: 2507187207
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus Aureus Bacteremia

Keywords

MRSA; MSSA

Outcome Measures

Primary Outcomes (3)

• Percentage of participants with prolonged bacteremia (≥ 6 days)

  Percentage of participants with prolonged bacteremia (≥ 6 days) up to 12 weeks post hospital discharge.

  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.

  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.

  Up to 12 weeks post hospital discharge

Secondary Outcomes (8)

• 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

Study Arms (2)

Early Dual IV Antibiotic Therapy

EXPERIMENTAL

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

Drug: Early Dual IV Antibiotic Therapy - MRSA; Drug: Early Dual IV Antibiotic Therapy - MSSA

Single Agent IV Antibiotic Therapy

ACTIVE COMPARATOR

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

Drug: Single Agent IV Antibiotic Therapy - MRSA; Drug: Single Agent IV Antibiotic Therapy - MSSA

Interventions

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.

Also known as: daptomycin, ceftaroline, rifampin

Early Dual IV Antibiotic Therapy

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.

Also known as: cefazolin, ertapenem, rifampin

Early Dual IV Antibiotic Therapy

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.

Also known as: daptomycin, vancomycin, ceftaroline, rifampin

Single Agent IV Antibiotic Therapy

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.

Also known as: cefazolin, oxacillin, nafcillin, rifampin

Single Agent IV Antibiotic Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (20)

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  BACKGROUND

MeSH Terms

Interventions

Daptomycin; Ceftaroline; Rifampin; Cefazolin; Ertapenem; Vancomycin; Oxacillin; Nafcillin

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Carbapenems; Glycopeptides; Glycoconjugates; Carbohydrates; Penicillins

Study Officials

• Joy J Juskowich, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

• Arif R Sawari, MD, MSc, MBA

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and COpAT Medical Director

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)