Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antibiotic Monotherapy (AM) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB), Antibiotic Monotherapy (AM) for patients with methicillin-resistant S. aureus bacteremia (MRSAB), Combination Antibiotic Therapy (CAT) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB), Combination Antibiotic Therapy (CAT) for patients with methicillin-resistant S. aureus bacteremia (MRSAB).
- Who it may be relevant to
- Registry conditions: Staphylococcus Aureus Bacteremia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
COMBAT-SAB: Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia
Overview
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.
Interventions
- 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
Primary outcome measures
- Desirability of Outcome Ranking (DOOR) [Time frame: From enrollment to 30 days post enrollment]
Secondary outcome measures (10)
- 90-day hospital-free days alive [Time frame: From enrollment to 90 days after enrollment]
- 30-day all cause mortality [Time frame: From enrollment to 30 days after enrollment]
- 90-day all-cause mortality [Time frame: From enrollment to 90 days after enrollment]
- 30-day bacteremia-free days [Time frame: From enrollment to 30 days after enrollment]
- Length of stay [Time frame: Measured at the time of hospital discharge, up to 30 days after enrollment]
- Total hospital direct costs [Time frame: Measured at the time of hospital discharge, up to 30 days after enrollment]
- Total inpatient antibiotic cost [Time frame: Measured at the time of hospital discharge, up to 30 days after enrollment]
- Combination antibiotic days [Time frame: Measured from the time of enrollment until study day 7, death, or hospital discharge]
- Antibiotic-associated adverse events [Time frame: From enrollment to 30 days after enrollment]
- Clostridioides difficile infection [Time frame: From enrollment to 30 days after hospital discharge]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patient requests that patient health data not be included in the analysis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- Platte Valley Hospital — Brighton
- Saint Joseph Hospital — Denver
- St. Mary's Regional Hospital — Grand Junction
- Good Samaritan Hospital — Lafayette
- Lutheran Medical Center — Wheat Ridge
- St. Vincent Regional Hospital — Billings
- St. James Hospital — Butte
- Holy Rosary Hospital — Miles City
- … and 5 more centers
Identifiers
NCT: NCT07376889 · 1053331