NCT03611257已完成不适用
Effect of Direct Rapid Antibiotic Susceptibility Testing (dRAST) on Treatment for Bacteremia in Patients With Hematologic Diseases: Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Percentage of patients receiving optimal targeted antibiotics 72 hours after blood collection for blood culture
研究概览
简要总结
The purpose of this study is to evaluate whether the use of direct rapid antibiotic susceptibility test (dRAST), in addition to the current standard antibiotic susceptibility test, can increase the proportion of patients with hematologic disease who received appropriate antibiotics in early period of bacteremia.
详细描述
- patients with hematologic diseases who have high risk of bacteremia, because of immune suppression treatment or intensive chemotherapy or bone marrow transplantation which these patients had received, will be recruited in tertiary referral medical centers.
- All the participants will be randomly assigned into either dRAST group or current standard antibiotic susceptibility test group.
- All the participants in the both arms will receive antimicrobial stewardship by infectious disease specialists. Antimicrobial stewardship will be performed at each timepoint of Gram stain results reporting, dRAST results reporting, and current method reporting.
- Target numbers are 58 and 58, respectively.
- All the participants will be monitored for general medical conditions such as vital sign and response to antibiotic treatment by infectious disease specialists for 1 week.
- The percentage of patients who received optimal targeted antibiotics 72 hours after blood collection for blood culture will be evaluated.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are expected to be admitted for more than 2 days due to treatment or complications of hematologic diseases (acute leukemia, chronic leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, aplastic anemia, etc.) in Seoul National University Hospital.
- •Patients with confirmed bacteremia
- •Patients who can understand the details of the clinical trial's explanation and provide the written consent
排除标准
- •Patients who are expected to stay in the hospital within 2 days
- •Patients without bacteremia during hospitalization
- •Patients who show fungemia without evidence of bacteremia
研究组 & 干预措施
Current standard method
Active Comparator
Hematologic patients with bacteremia will receive antibiotics based on current standard method results.
干预措施: Current standard method (Diagnostic Test)
dRAST
Experimental
Hematologic patients with bacteremia will receive antibiotics based on "dRAST" results.
干预措施: dRAST (Diagnostic Test)
结局指标
主要结局
Percentage of patients receiving optimal targeted antibiotics 72 hours after blood collection for blood culture
时间窗: 72 hour after blood culture collection
The percentage of patients receiving optimal targeted antibiotics antibiotics which is defined as most effective and narrowest antibiotics based on susceptibility testing results, 72 hours after blood collection for blood culture
次要结局
- Amount of broad-spectrum antibiotics use(Time from first blood culture collection up to 1 week)
- Time to defervescence(Time from first blood culture collection up to 1 month)
- Time to optimal targeted antibiotics(Time from first blood culture collection up to 1 month)
- Percentage of patients receiving unnecessary broad spectrum antibiotics 72 hours after(72 hour after blood culture collection)
- proportion of positive blood culture 48 hours after first blood culture(Time from blood culture collection up to 1 month)
- Percentage of patients receiving ineffective antibiotics 72 hours after(72 hour after blood culture collection)
- 30-day mortality rate related with bacteremia(Time from blood culture collection up to 30-day)
- Percentage of patients receiving optimal targeted antibiotics 48 hours after(48 hour after blood culture collection)
- Percentage of patients receiving unnecessary broad spectrum antibiotics 48 hours after(48 hour after blood culture collection)
- Percentage of patients receiving ineffective antibiotics 48 hours after(48 hour after blood culture collection)
研究者
Wan Beom Park
Professor
Seoul National University Hospital
研究点 (2)
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