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Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?

NCT07148960 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-09-17

No results posted yet for this study

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

Interventions

DRUG

Early Dual IV Antibiotic Therapy - MRSA

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

DRUG

Early Dual IV Antibiotic Therapy - MSSA

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

DRUG

Single Agent IV Antibiotic Therapy - MRSA

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

DRUG

Single Agent IV Antibiotic Therapy - MSSA

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

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • Joy J Juskowich, MD · West Virginia University

  • Arif R Sawari, MD, MSc, MBA · West Virginia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148960 on ClinicalTrials.gov