Dual Antibiotic Therapy for Staph Bacteremia

(SABEDTIO Trial)

Overseen By Arif R Sarwari, MD, MSc, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: West Virginia University

Disqualifiers: Prisoner, Pregnant, Mentally handicapped, others

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: Up to 14 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether using two antibiotics early is more effective than one for treating Staphylococcus aureus bacteremia, a serious blood infection. Researchers aim to determine if this approach can shorten infection duration and improve recovery. Participants will be assigned to receive either dual or single antibiotic treatment through an IV (intravenous), then switch to pill form once the infection clears. This trial suits individuals with this specific blood infection who are hospitalized at certain medical centers. Participants will have regular check-ups and calls with the Infectious Diseases Clinic during the trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand its benefits for more patients.

Will I have to stop taking my current medications?

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

What is the safety track record for these treatments?

Research has shown that using two antibiotics together for Staphylococcus aureus bacteremia (SAB) might help clear the infection faster. In some studies, patients who took a combination like daptomycin and ceftaroline improved more quickly. However, using two antibiotics simultaneously can lead to more side effects. For instance, one study found that while this combination might not reduce the risk of death, it could increase the chance of unwanted side effects.

On the positive side, when patients received daptomycin plus ceftaroline, many could switch to a simpler treatment after about 12.5 days. It's important to weigh these potential risks and benefits when considering this treatment option. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the dual antibiotic therapy for Staph bacteremia because it takes a more aggressive approach by combining two antibiotics. For MRSA infections, combining daptomycin with ceftaroline may enhance effectiveness compared to using them separately. For MSSA infections, the combination of cefazolin and ertapenem offers a potential boost in fighting the bacteria. This dual approach could lead to faster recovery times and improved outcomes, particularly in complicated infections involving resistant strains.

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

This trial will compare the effectiveness of dual antibiotic therapy with single-agent therapy for treating Staphylococcus aureus bacteremia (SAB). Research has shown that using two antibiotics together can be more effective than using just one. Participants in the dual therapy arm will receive combinations like cefazolin and ertapenem for methicillin-sensitive cases (MSSA) or daptomycin and ceftaroline for methicillin-resistant cases (MRSA). Studies have found that these combinations cleared stubborn cases of SAB more effectively. Although some research suggests that using two antibiotics might increase the risk of side effects, it could still offer a faster and more effective treatment for SAB. ^{2 3 6 7 8}

Who Is on the Research Team?

Joy J Juskowich, MD

Principal Investigator

West Virginia University

Arif R Sawari, MD, MSc, MBA

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

This trial is for patients with Staphylococcus aureus bacteremia. They must be willing to be randomly assigned to receive either two IV antibiotics (early dual therapy) or one IV antibiotic (single agent). After the infection clears, treatment will switch to oral antibiotics.

Inclusion Criteria

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

Exclusion Criteria

The patient is a prisoner, pregnant, and/or mentally handicapped

My doctor thinks it's not safe for me to join the study.

I cannot give consent, and no one can do it on my behalf.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive early dual or single IV antibiotic therapy based on randomization, followed by a transition to oral antibiotics once blood cultures are negative.

Up to 14 days

Weekly lab tests and follow-up in person or by telephone or video in ID Clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of all-cause mortality and other clinical outcomes.

12 weeks

Follow-up in person or by telephone or video in ID Clinic

What Are the Treatments Tested in This Trial?

Interventions

• Early Dual IV Antibiotic Therapy

Trial Overview The study compares early dual IV antibiotic therapy versus single-agent IV therapy in treating Staph bacteremia. The aim is to see if the dual approach shortens infection duration and improves outcomes, with a transition from IV to oral antibiotics after blood cultures clear.

How Is the Trial Designed?

Group I: Early Dual IV Antibiotic Therapy Experimental Treatment 2 Interventions

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

Group II: Single Agent IV Antibiotic Therapy Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Citations

1. mdpi.com mdpi.com/2076-2607/10/5/848

The Effectiveness of Combination Therapy for Treating ... Combination therapy not only did not decrease mortality in patients with MSSA bacteremia, but also increased the risk of adverse events.

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/20499361251343969

Adjunctive β-lactams for Staphylococcus aureus bacteremia Comparing the outcomes of ceftaroline plus vancomycin or daptomycin combination therapy versus vancomycin or daptomycin monotherapy in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5075066/

Cefazolin and Ertapenem, a Synergistic Combination Used ... Ertapenem and cefazolin were used in combination to successfully clear refractory methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0924857921000406

Combination ceftaroline and daptomycin salvage therapy ... Daptomycin and ceftaroline combination reduced the incidence of clinical failure. Daptomycin and ceftaroline may decrease the time to blood culture clearance.

5. pediatrics.ucsd.edu pediatrics.ucsd.edu/_files/pdfs/lab-nizet-pdfs/MRSA-cefteroline.pdf

Enhanced Killing of Methicillin-Resistant Staphylococcus ... The Journal of Infectious Diseases®​​ Our recent studies have demonstrated the efficacy of combining ertapenem with cefazolin or other anti-staphylococcal β- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12171258/

Adjunctive β-lactams for Staphylococcus aureus bacteremia Comparing the outcomes of ceftaroline plus vancomycin or daptomycin combination therapy versus vancomycin or daptomycin monotherapy in ...

7. contagionlive.com contagionlive.com/view/persistent-methicillin-susceptible-staphylococcus-aureus-mssa-bacteremia

Treating Persistent Methicillin-susceptible Staphylococcus ... Reported outcomes with cefazolin or oxacillin in combination with daptomycin or ertapenem based on limited data appear promising, with clearance ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36690124/

Outcomes of Daptomycin Plus Ceftaroline Versus Alternative ... Daptomycin plus ceftaroline was de-escalated in 81% of patients after receiving combination therapy for an average of 12.5 days. Secondary outcomes, including ...