Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes? (SABEDTIO) Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percentage of participants with prolonged bacteremia (≥ 6 days)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is hospitalized at J.W. Ruby Memorial Hospital, Berkeley Medical Center, Camden Clark Medical Center, Princeton Community Hospital, Thomas 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
排除标准
- •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
研究组 & 干预措施
Early Dual IV Antibiotic Therapy
Once type of Staphylococcus aureus bacteremia (MRSA vs. MSSA) is determined the following IV antibiotics will be given:
- MRSA - daptomycin plus ceftaroline;
- MSSA - cefazolin plus ertapenem;
- MRSA or MSSA - rifampin PO may be added for patients with prosthetic material
干预措施: Early Dual IV Antibiotic Therapy - MSSA (Drug)
Early Dual IV Antibiotic Therapy
Once type of Staphylococcus aureus bacteremia (MRSA vs. MSSA) is determined the following IV antibiotics will be given:
- MRSA - daptomycin plus ceftaroline;
- MSSA - cefazolin plus ertapenem;
- MRSA or MSSA - rifampin PO may be added for patients with prosthetic material
干预措施: Early Dual IV Antibiotic Therapy - MRSA (Drug)
Single Agent IV Antibiotic Therapy
Once type of Staphylococcus aureus bacteremia (MRSA vs. MSSA) is determined the following IV antibiotics will be given:
- MRSA - daptomycin, vancomycin, or ceftaroline;
- MSSA - cefazolin, oxacillin, or nafcillin;
- MRSA or MSSA - rifampin PO may be added for patients with prosthetic material
干预措施: Single Agent IV Antibiotic Therapy - MRSA (Drug)
Single Agent IV Antibiotic Therapy
Once type of Staphylococcus aureus bacteremia (MRSA vs. MSSA) is determined the following IV antibiotics will be given:
- MRSA - daptomycin, vancomycin, or ceftaroline;
- MSSA - cefazolin, oxacillin, or nafcillin;
- MRSA or MSSA - rifampin PO may be added for patients with prosthetic material
干预措施: Single Agent IV Antibiotic Therapy - MSSA (Drug)
结局指标
主要结局
Percentage of participants with prolonged bacteremia (≥ 6 days)
时间窗: 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
时间窗: 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
时间窗: Up to 12 weeks post hospital discharge
Number of participants who died from any cause up to 12 weeks post hospital discharge.
次要结局
- Number of patients with cure/control(Up to 12 weeks post hospital discharge)
- Time to Positivity (TTP)(Up to 14 days post hospital admission)
- Sequential Time to Positivity (STTP)(Up to 14 days post hospital admission)
- Length of Hospital Stay(Up to 12 weeks post hospital discharge)
- Overall Hospital Readmission(Up to 12 weeks post hospital discharge)
- Rate of Relapsed Bacteremia(Up to 12 weeks post hospital discharge)
- Time to First Negative Blood Culture(Up to 14 days post hospital admission)
- Incidence of Antibiotic-Associated Side Effects and Toxicity(Up to 12 weeks post hospital discharge)
研究者
Joy J. Juskowich, MD
Assistant Professor and COpAT Medical Director
West Virginia University