Combination Antibiotic Therapy for Staph Bacteremia

(COMBAT-SAB Trial)

Not yet recruiting at 12 trial locations
BJ
WR
Overseen ByWhitney R Buckel, PharmD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Intermountain Health Care, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a combination of antibiotics versus a single antibiotic in treating serious blood infections caused by specific bacteria. It focuses on patients with either methicillin-sensitive Staphylococcus aureus (MSSA) or methicillin-resistant Staphylococcus aureus (MRSA), both of which can cause these infections. Participants will receive either one antibiotic or a combination to determine which method is more effective. Patients diagnosed with a Staph infection in the blood while staying at an Intermountain Health hospital may be suitable for this study. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

Research has shown that using a combination of antibiotics for methicillin-sensitive Staphylococcus aureus bacteremia (MSSAB) might not reduce the risk of death. However, it may increase the likelihood of side effects, such as drug reactions and kidney issues. This indicates that while the treatment might not significantly reduce mortality from the infection, it could lead to more side effects.

For methicillin-resistant Staphylococcus aureus bacteremia (MRSAB), studies suggest that a combination of antibiotics could lower the risk of death compared to a single antibiotic. This is promising, but using multiple antibiotics can sometimes cause side effects.

Both treatments have been tested in people. The findings suggest that while combination therapy may offer some benefits, there is also a risk of side effects. Participants should consider these factors and discuss them with their healthcare provider.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about combination antibiotic therapy for Staph bacteremia because it offers a potential edge over the standard monotherapy. For patients with methicillin-sensitive S. aureus bacteremia (MSSAB) and methicillin-resistant S. aureus bacteremia (MRSAB), this approach uses a strategic mix of antibiotics, which could enhance effectiveness by attacking the bacteria from multiple angles. This method might improve outcomes by reducing treatment failure rates and preventing the development of antibiotic resistance. Unlike standard treatments that typically rely on a single antibiotic, combination therapy could provide a more robust defense against these tough infections.

What evidence suggests that this trial's treatments could be effective for Staph bacteremia?

Research shows that a combination of antibiotics works differently depending on the type of Staphylococcus aureus blood infection. In this trial, participants with methicillin-sensitive S. aureus bacteremia (MSSAB) will receive either antibiotic monotherapy or combination antibiotic therapy. Studies have found that using more than one antibiotic for MSSAB did not reduce death rates and even increased the chance of side effects. Meanwhile, participants with methicillin-resistant S. aureus bacteremia (MRSAB) will also receive either monotherapy or combination therapy. Evidence suggests that a combination of antibiotics for MRSAB can lower death rates compared to monotherapy, indicating that combining antibiotics might be more effective specifically for treating MRSAB.12346

Who Is on the Research Team?

BJ

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?

2

Treatment groups

Experimental Treatment

Group I: Patients with methicillin-sensitive S. aureus bacteremia (MSSAB)Experimental Treatment2 Interventions
Group II: Patients with methicillin-resistant S. aureus bacteremia (MRSAB)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials
142
Recruited
1,965,000+

Citations

The Effectiveness of Combination Therapy for Treating ... - PMC

Conclusions: Combination therapy not only did not decrease mortality in patients with MSSA bacteremia, but also increased the risk of adverse events.

Clinical Outcomes With Definitive Treatment of Methicillin ...

Lower mortality has been observed with combination therapy compared to monotherapy for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia.

Combination Antibiotic Therapy for Staphylococcus Aureus ...

The purpose of this study is to see if, in selected patients with a serious bacterial infection of the bloodstream, treating the bacterial ...

Current Paradigms of Combination Therapy in Methicillin ...

This review consolidates the recent data on combination therapy for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia, provides perspective on ...

Effect of Vancomycin or Daptomycin With vs Without an ...

Vancomycin has reduced efficacy against MSSA compared with antistaphylococcal β-lactams. A growing body of evidence suggests that adding a β- ...

Outcomes of Daptomycin Plus Ceftaroline Versus ...

Prolonging ceftaroline combination therapy after bacteremia clearance did not significantly improve outcomes in patients with persistent or high-grade MRSA ...