NCT07376889

Brief Summary

The purpose of this study is to see if, in selected patients with a serious bacterial infection of the bloodstream, treating the bacterial infection with a combination of antibiotics is more effective than treating the infection with a single antibiotic. Participants must have blood cultures which are positive for a certain type of bacteria.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,096

participants targeted

Target at P75+ for phase_4

Timeline
33mo left

Started Feb 2026

Typical duration for phase_4

Geographic Reach
1 country

13 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Jan 2029

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

January 21, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

Combination antibiotic therapy

Outcome Measures

Primary Outcomes (1)

  • Desirability of Outcome Ranking (DOOR)

    The DOOR ordinal scale includes four possible outcomes: treatment failure, infectious complications, antibiotic-associated adverse events and death. The ordinal scale comprises five levels: levels 1-4 are defined by survival at 30 days and the presence of either none, one, two or three of three possible outcomes; level 5 indicates death before 30 days. A DOOR analysis estimates the probability that overall outcomes in any given subject in one group are overall superior to those in a random subject from the other treatment group; probabilities \>50% reject the null hypothesis.

    From enrollment to 30 days post enrollment

Secondary Outcomes (10)

  • 90-day hospital-free days alive

    From enrollment to 90 days after enrollment

  • 30-day all cause mortality

    From enrollment to 30 days after enrollment

  • 90-day all-cause mortality

    From enrollment to 90 days after enrollment

  • 30-day bacteremia-free days

    From enrollment to 30 days after enrollment

  • Length of stay

    Measured at the time of hospital discharge, up to 30 days after enrollment

  • +5 more secondary outcomes

Study Arms (2)

Patients with methicillin-sensitive S. aureus bacteremia (MSSAB)

EXPERIMENTAL

Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) will be assigned to one of two different antibiotic treatment strategies appropriate for MSSA: 1) antibiotic monotherapy, or 2) combination antibiotic therapy

Drug: Antibiotic Monotherapy (AM) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB)Drug: Combination Antibiotic Therapy (CAT) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB)

Patients with methicillin-resistant S. aureus bacteremia (MRSAB)

EXPERIMENTAL

Patients with methicillin-resistant S. aureus bacteremia (MRSAB) will be assigned to one of two different antibiotic treatment strategies appropriate for MRSA: 1) antibiotic monotherapy, or 2) combination antibiotic therapy

Drug: Antibiotic Monotherapy (AM) for patients with methicillin-resistant S. aureus bacteremia (MRSAB)Drug: Combination Antibiotic Therapy (CAT) for patients with methicillin-resistant S. aureus bacteremia (MRSAB)

Interventions

Intravenous anti-staphylococcal beta-lactam, either cefazolin or nafcillin, per the discretion of the treating physician.

Patients with methicillin-sensitive S. aureus bacteremia (MSSAB)

Vancomycin or daptomycin, per discretion of the treating physician

Patients with methicillin-resistant S. aureus bacteremia (MRSAB)

Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) and no contraindications will receive an anti-staphylococcal beta-lactam, either cefazolin or nafcillin, plus ertapenem

Patients with methicillin-sensitive S. aureus bacteremia (MSSAB)

Daptomycin plus ceftaroline

Patients with methicillin-resistant S. aureus bacteremia (MRSAB)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Alive and admitted to an Intermountain Health (IH) hospital acute care unit at enrollment
  • Initial positive blood culture with either methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-susceptible Staphylococcus aureus (MSSA), collected:
  • on or during the index admission to an IH hospital, or
  • in an ambulatory setting (laboratory, clinic or emergency department) within 48 hours of the index admission, or
  • at a non-IH network hospital within 24 hours of subsequent transfer to an IH hospital

You may not qualify if:

  • Patient requests that patient health data not be included in the analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Platte Valley Hospital

Brighton, Colorado, 80601, United States

Location

Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

St. Mary's Regional Hospital

Grand Junction, Colorado, 81501, United States

Location

Good Samaritan Hospital

Lafayette, Colorado, 80026, United States

Location

Lutheran Medical Center

Wheat Ridge, Colorado, 80401, United States

Location

St. Vincent Regional Hospital

Billings, Montana, 59101, United States

Location

St. James Hospital

Butte, Montana, 59701, United States

Location

Holy Rosary Hospital

Miles City, Montana, 59301, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Utah Valley Hospital

Provo, Utah, 84604, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

St. George Regional Hospital

St. George, Utah, 84790, United States

Location

Study Officials

  • Brandon J Webb, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon J Webb, MD

CONTACT

Whitney R Buckel, PharmD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Platform, embedded, pragmatic clinical trial using a multiple-crossover cluster-randomized design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Research, Division of Infectious Diseases

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 29, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org

Time Frame
Data sharing will be available six months after anticipated enrollment completion, estimated August 2029, for a period to be determined by the Intermountain Office of Research and IRB
Access Criteria
Will be determined on an individual basis, upon request to the IH Office of Research.

Locations