COMBAT-SAB: Combination Antibiotic Therapy for Staphylococcus Aureus Bacteremia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,096
- 试验地点
- 26
- 主要终点
- Desirability of Outcome Ranking (DOOR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •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
排除标准
- •Patient requests that patient health data not be included in the analysis
研究组 & 干预措施
Patients with methicillin-sensitive S. aureus bacteremia (MSSAB)
Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) will be assigned to one of two different antibiotic treatment strategies appropriate for MSSA: 1) antibiotic monotherapy, or 2) combination antibiotic therapy
干预措施: Antibiotic Monotherapy (AM) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB) (Drug)
Patients with methicillin-sensitive S. aureus bacteremia (MSSAB)
Patients with methicillin-sensitive S. aureus bacteremia (MSSAB) will be assigned to one of two different antibiotic treatment strategies appropriate for MSSA: 1) antibiotic monotherapy, or 2) combination antibiotic therapy
干预措施: Combination Antibiotic Therapy (CAT) for patients with methicillin-sensitive S. aureus bacteremia (MSSAB) (Drug)
Patients with methicillin-resistant S. aureus bacteremia (MRSAB)
Patients with methicillin-resistant S. aureus bacteremia (MRSAB) will be assigned to one of two different antibiotic treatment strategies appropriate for MRSA: 1) antibiotic monotherapy, or 2) combination antibiotic therapy
干预措施: Antibiotic Monotherapy (AM) for patients with methicillin-resistant S. aureus bacteremia (MRSAB) (Drug)
Patients with methicillin-resistant S. aureus bacteremia (MRSAB)
Patients with methicillin-resistant S. aureus bacteremia (MRSAB) will be assigned to one of two different antibiotic treatment strategies appropriate for MRSA: 1) antibiotic monotherapy, or 2) combination antibiotic therapy
干预措施: Combination Antibiotic Therapy (CAT) for patients with methicillin-resistant S. aureus bacteremia (MRSAB) (Drug)
结局指标
主要结局
Desirability of Outcome Ranking (DOOR)
时间窗: 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.
次要结局
- 90-day hospital-free days alive(From enrollment to 90 days after enrollment)
- 30-day all cause mortality(From enrollment to 30 days after enrollment)
- 90-day all-cause mortality(From enrollment to 90 days after enrollment)
- 30-day bacteremia-free days(From enrollment to 30 days after enrollment)
- Length of stay(Measured at the time of hospital discharge, up to 30 days after enrollment)
- Total hospital direct costs(Measured at the time of hospital discharge, up to 30 days after enrollment)
- Total inpatient antibiotic cost(Measured at the time of hospital discharge, up to 30 days after enrollment)
- Combination antibiotic days(Measured from the time of enrollment until study day 7, death, or hospital discharge)
- Antibiotic-associated adverse events(From enrollment to 30 days after enrollment)
- Clostridioides difficile infection(From enrollment to 30 days after hospital discharge)
研究者
Brandon Webb
Associate Professor of Research, Division of Infectious Diseases
Intermountain Health Care, Inc.