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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2,096
Intravenous anti-staphylococcal beta-lactam, either cefazolin or nafcillin, per the discretion of the treating physician.
Vancomycin or daptomycin, per discretion of the treating physician
Platte Valley Hospital
Brighton, Colorado, United States
NOT_YET_RECRUITINGSaint Joseph Hospital
Denver, Colorado, United States
Desirability of Outcome Ranking (DOOR)
The DOOR ordinal scale includes four possible outcomes: treatment failure, infectious complications, antibiotic-associated adverse events and death. The ordinal scale comprises five levels: levels 1-4 are defined by survival at 30 days and the presence of either none, one, two or three of three possible outcomes; level 5 indicates death before 30 days. A DOOR analysis estimates the probability that overall outcomes in any given subject in one group are overall superior to those in a random subject from the other treatment group; probabilities \>50% reject the null hypothesis.
Time frame: From enrollment to 30 days post enrollment
90-day hospital-free days alive
Number of days the patient is alive and out of the hospital
Time frame: From enrollment to 90 days after enrollment
30-day all cause mortality
Number of deaths from any cause within 30 days after enrollment
Time frame: From enrollment to 30 days after enrollment
90-day all-cause mortality
Number of deaths from any cause within 90 days after enrollment
Time frame: From enrollment to 90 days after enrollment
30-day bacteremia-free days
Number of days without bacteremia within 30 days after enrollment
Time frame: From enrollment to 30 days after enrollment
Length of stay
Number of days in the hospital following enrollment
Time frame: Measured at the time of hospital discharge, up to 30 days after enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) and no contraindications will receive an anti-staphylococcal beta-lactam, either cefazolin or nafcillin, plus ertapenem
Daptomycin plus ceftaroline
St. Mary's Regional Hospital
Grand Junction, Colorado, United States
NOT_YET_RECRUITINGGood Samaritan Hospital
Lafayette, Colorado, United States
NOT_YET_RECRUITINGLutheran Medical Center
Wheat Ridge, Colorado, United States
NOT_YET_RECRUITINGSt. Vincent Regional Hospital
Billings, Montana, United States
NOT_YET_RECRUITINGSt. James Hospital
Butte, Montana, United States
NOT_YET_RECRUITINGHoly Rosary Hospital
Miles City, Montana, United States
NOT_YET_RECRUITINGIntermountain Medical Center
Murray, Utah, United States
RECRUITINGMcKay-Dee Hospital
Ogden, Utah, United States
NOT_YET_RECRUITING...and 3 more locations
Total hospital direct costs
Total financial charges incurred by a patient during their hospitalization
Time frame: Measured at the time of hospital discharge, up to 30 days after enrollment
Total inpatient antibiotic cost
Total cost of all antibiotics received by a patient while hospitalized
Time frame: Measured at the time of hospital discharge, up to 30 days after enrollment
Combination antibiotic days
Number of days a patient receives combination antibiotic therapy (CAT) as defined in protocol, instead of antibiotic monotherapy (AM)
Time frame: Measured from the time of enrollment until study day 7, death, or hospital discharge
Antibiotic-associated adverse events
Number and type of patient adverse events definitively associated with the receipt of antibiotics while hospitalized
Time frame: From enrollment to 30 days after enrollment
Clostridioides difficile infection
Presence of infection with Clostridioides difficile while hospitalized
Time frame: From enrollment to 30 days after hospital discharge