Combination Antibiotic Therapy for Staph Bacteremia

(COMBAT-SAB Trial)

Not yet recruiting at 12 trial locations

Overseen By Whitney R Buckel, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Intermountain Health Care, Inc.

Disqualifiers: Patient data exclusion request

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Brandon J Webb, MD

Principal Investigator

Intermountain Health Care, Inc.

Are You a Good Fit for This Trial?

This trial is for patients with a serious bloodstream infection known as Staphylococcus aureus bacteremia. Participants must have blood cultures positive for this bacteria, either methicillin-resistant (MRSAB) or methicillin-sensitive (MSSAB).

Inclusion Criteria

Alive and admitted to an Intermountain Health (IH) hospital acute care unit at enrollment

I am 18 years old or older.

I have a confirmed blood infection with MRSA or MSSA.

Exclusion Criteria

I do not want my health data used in the study analysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either antibiotic monotherapy or combination antibiotic therapy based on random assignment

7 days

Daily monitoring during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Regular follow-up visits as needed

Extended Follow-up

Participants are monitored for long-term outcomes such as hospital-free days and mortality

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Combination Antibiotic Therapy

Trial Overview

The study compares the effectiveness of using a combination of antibiotics versus a single antibiotic to treat Staph bacteremia. There are four groups: CAT and AM each for MRSAB and MSSAB patients.

How Is the Trial Designed?

Group I: Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) Experimental Treatment 2 Interventions

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

Group II: Patients with methicillin-resistant S. aureus bacteremia (MRSAB) Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+