NCT07376889

Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia

COMBAT-SAB: Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,096 (estimated)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Staphyloccocus aureus bacteremia (SAB) is a common infectious disease condition in hospitalized patients which is associated with significant morbidity, excessive costs, and high mortality, despite effective antibiotic therapy. This pragmatic study is designed to test the hypothesis that outcomes in adults hospitalized with SAB will be improved by using combination antibiotic therapy (CAT) as early, targeted therapy in a high-risk subgroup. A group of patients identified early in their course as meeting at least one high-risk criterion who have no contraindications will be treated with one of two antibiotic strategies commonly used within usual care, namely: 1) antibiotic monotherapy or 2) combination antibiotic therapy, depending on the random assignment for each hospital, each month. Low-risk patients will be treated per usual care. Data from all patients admitted to participating hospitals with SAB will be included in the analysis.

Conditions

• Staphylococcus Aureus Bacteremia

Interventions

Type	Name	Description
DRUG	Antibiotic Monotherapy (AM) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB)	Intravenous anti-staphylococcal beta-lactam, either cefazolin or nafcillin, per the discretion of the treating physician.
DRUG	Antibiotic Monotherapy (AM) for patients with methicillin-resistant S. aureus bacteremia (MRSAB)	Vancomycin or daptomycin, per discretion of the treating physician
DRUG	Combination Antibiotic Therapy (CAT) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB)	Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) and no contraindications will receive an anti-staphylococcal beta-lactam, either cefazolin or nafcillin, plus ertapenem
DRUG	Combination Antibiotic Therapy (CAT) for patients with methicillin-resistant S. aureus bacteremia (MRSAB)	Daptomycin plus ceftaroline

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2026-01-29
• Last updated: 2026-01-29

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study