Staphylococcus Aureus Bacteremia
Conditions
Keywords
MRSA, MSSA
Brief summary
The goal of this open-label, pragmatic, randomized controlled clinical trial is to learn if patients with Staphylococcus aureus bacteremia (SAB) given the intervention of early dual intravenous (IV) antibiotic therapy will decrease duration of bacteremia (\< 6 days) and improve outcomes compared to single IV antibiotic therapy. The main questions this study aims to answer are: * To decrease SAB duration and improve outcomes by using early dual vs. single agent IV antibiotic therapy * To accelerate practice transformation of earlier IV to oral (PO) antibiotic transition by switching to PO antibiotic therapy once blood cultures are negative at 72 hours Participants will be asked to agree to be randomized (like flipping a coin) to receive two or one IV antibiotic(s). Once the infection has cleared, the treatment will be changed to PO antibiotics. As part of usual care, participants will have weekly lab tests for monitoring while on antibiotics, receive a telephone call to see how the participants are doing, and follow up in person or by telephone or video in Infectious Diseases (ID) Clinic. Participant participation will last 12 weeks after the participant is discharged from the hospital.
Interventions
DRUGEarly Dual IV Antibiotic Therapy - MRSA
Participant given IV daptomycin plus ceftaroline dosing per standard of care. Oral rifampin may be added for participants with prosthetic material.
DRUGEarly Dual IV Antibiotic Therapy - MSSA
Participant given IV cefazolin plus ertapenem dosing per standard of care. Oral rifampin may be added for participants with prosthetic material.
DRUGSingle Agent IV Antibiotic Therapy - MRSA
Participant given one of the following IV therapies: daptomycin, vancomycin, or ceftaroline. Oral rifampin may be added for participants with prosthetic material.
DRUGSingle Agent IV Antibiotic Therapy - MSSA
Participant given one of the following IV therapies: cefazolin, oxacillin, or nafcillin. Oral rifampin may be added for participants with prosthetic material.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient is hospitalized at J.W. Ruby Memorial Hospital, Berkeley Medical Center, Camden Clark Medical Center, Princeton Community 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 or an appointed medical decision maker is unable to give informed consent * The patient is a prisoner, pregnant, and/or mentally handicapped * The patient is determined unsafe for enrollment at the primary team's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with prolonged bacteremia (≥ 6 days) | Up to 12 weeks post hospital discharge | Percentage of participants with prolonged bacteremia (≥ 6 days) up to 12 weeks post hospital discharge. |
| Seeding of a New Site - Incidence | Up to 12 weeks post hospital discharge | Incidence of new infection of heart valve, joint, or spine up to 12 weeks post hospital discharge. |
| All-Cause Mortality | Up to 12 weeks post hospital discharge | Number of participants who died from any cause up to 12 weeks post hospital discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with cure/control | Up to 12 weeks post hospital discharge | Number of patients with cure/control using clinical (resolution of infection - e.g., wound healed) and laboratory (improvement in inflammatory markers - e.g., CRP normalization) parameters. |
| Time to Positivity (TTP) | Up to 14 days post hospital admission | Time in hours from first set of blood culture bottle on laboratory instrument to positive culture bottle off laboratory instrument (TTP1). |
| Sequential Time to Positivity (STTP) | Up to 14 days post hospital admission | Ratio of the Time to Positivity of the second set of blood cultures divided by the first set of blood cultures (TTP2/TTP1). |
| Length of Hospital Stay | Up to 12 weeks post hospital discharge | Duration in days from hospital admission to hospital discharge. |
| Overall Hospital Readmission | Up to 12 weeks post hospital discharge | Number of participants readmitted for any reason up to 12 weeks after discharge from the hospital. |
| Rate of Relapsed Bacteremia | Up to 12 weeks post hospital discharge | Recurrence of bacteremia with the same organism one week after initial clearance. |
| Time to First Negative Blood Culture | Up to 14 days post hospital admission | Time from hospital admission to the first documented negative blood culture. |
| Incidence of Antibiotic-Associated Side Effects and Toxicity | Up to 12 weeks post hospital discharge | Occurrence of adverse events related to antibiotic therapy, including Clostridioides difficile infection, as assessed by clinical evaluation and laboratory testing. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoy J Juskowich, MD
West Virginia University
PRINCIPAL_INVESTIGATORArif R Sawari, MD, MSc, MBA
West Virginia University
Outcome results
None listed