Antibiotic Monotherapy (AM) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB)
DrugIntravenous anti-staphylococcal beta-lactam, either cefazolin or nafcillin, per the discretion of the treating physician.
NCT Number: NCT07376889
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Platte Valley Hospital, Brighton, Colorado, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: From enrollment to 30 days post enrollment
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 90 days after enrollment
Number of days the patient is alive and out of the hospital
Time frame: From enrollment to 30 days after enrollment
Number of deaths from any cause within 30 days after enrollment
Time frame: From enrollment to 90 days after enrollment
Number of deaths from any cause within 90 days after enrollment
Time frame: From enrollment to 30 days after enrollment
Number of days without bacteremia within 30 days after enrollment
Time frame: Measured at the time of hospital discharge, up to 30 days after enrollment
Number of days in the hospital following enrollment
Time frame: Measured at the time of hospital discharge, up to 30 days after enrollment
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 cost of all antibiotics received by a patient while hospitalized
Time frame: Measured from the time of enrollment until study day 7, death, or hospital discharge
Number of days a patient receives combination antibiotic therapy (CAT) as defined in protocol, instead of antibiotic monotherapy (AM)
Time frame: From enrollment to 30 days after enrollment
Number and type of patient adverse events definitively associated with the receipt of antibiotics while hospitalized
Time frame: From enrollment to 30 days after hospital discharge
Presence of infection with Clostridioides difficile while hospitalized
Contact information is provided by the study sponsor or research team.
Brandon J Webb, MD
CONTACT
Whitney R Buckel, PharmD
CONTACT
Intermountain Health Care, Inc.
Other
COMBAT-SAB: Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia
Acronym: COMBAT-SAB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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