Etiologic Diagnosis Algorithm in Infective Endocarditis
2026年6月28日 更新者：I.M. Sechenov First Moscow State Medical University
Development and Validation of An Algorithm of Etiological Diagnosis of Infective Endocarditis in Adults: An Open-Label Multicenter Randomized Clinical Trial
The goal of this study is to evaluate the impact of a diagnostic algorithm combining culture-based and molecular methods on the frequency of etiotropic antibiotic therapy prescription within 14 days of diagnosis of infective endocarditis
研究概览
详细说明
This is an open-label (with blinded endpoint assessment) multicenter randomized trial designed to evaluate the impact of an etiological diagnostic algorithm incorporating various laboratory methods (culture-based and molecular) on the frequency of etiological antibiotic therapy prescription within 14 days after the diagnosis of infective endocarditis.
While molecular samples are collected from all participants, results are only disclosed to physicians in the intervention group to guide treatment, while remaining blinded in the control group.
研究类型
介入性
注册 (估计的)
128
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Svetlana Rachina, Professor
- 电话号码：+7 910 715-89-55
- 邮箱：rachina_s_a@staff.sechenov.ru
学习地点
-
-
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Moscow、俄罗斯
- 尚未招聘
- A.N. Bakulev National Medical Research Center for Cardiovascular Surgery of the Russian Ministry of Health
-
接触：
- Dmitry Popov, Prof
-
Moscow、俄罗斯
- 招聘中
- City Clinical Hospital Named After S. S. Yudin
-
接触：
- Svetlana Rachina
- 电话号码：+7 910 715-89-55
- 邮箱：rachina_s_a@staff.sechenov.ru
-
Moscow、俄罗斯
- 招聘中
- City Clinical Hospital №67 Named After L. A. Vorokhobova
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接触：
- Svetlana Mirzakhamidova, Dr
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Informed consent,
- Age ≥ 18,
- IE (definite or possible per the 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis)
Exclusion Criteria:
- Pregnancy/breastfeeding
- Unconfirmed or rejected IE diagnosis,
- Very high risk of death within 14 days due to severe complications of the main or concomitant disease(s), according to the physician's opinion;
- Prior use of antibiotic therapy (except documented treatment failure).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Comprehensive Etiological Diagnosis Group
Patients receive standard diagnostics plus molecular test results (PCR, PCR with sequencing) to guide etiotropic therapy
|
PCR and PCR with consequent sequencing of the blood (or tissue) will be performed in addition to the cultural methods in the experimental study arm
|
|
有源比较器：Standard Clinical Practice Group
Patients receive standard care; molecular test results are blinded for the treating physician
|
Patients receive standard care with analysis of microorganisms in at least 2 or more separate blood culture sets and from cardiac tissue (if surgical treatment is performed); molecular test results are blinded for the treating physician
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Frequency of etiotropic antibiotic therapy prescription
大体时间：14 days from the date of diagnosis
|
Proportion of patients receiving specific ABT within 14 days of diagnosis
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14 days from the date of diagnosis
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
IE Complications requiring surgical treatment
大体时间：At discharge (an average of 14 days)
|
Proportion of patients with IE-related complications (uncontrolled infection, heart failure, or embolic events) requiring surgical treatment during hospitalization
|
At discharge (an average of 14 days)
|
|
Acute Kidney Injury
大体时间：At discharge (an average of 14 days)
|
Proportion of patients with acute kidney injury during hospitalization, defined as: increase in serum creatinine by ≥26.5 μmol/L within 48 hours, or increase in serum creatinine to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days, or urine output <0.5 mL/kg/h for 6 hours. |
At discharge (an average of 14 days)
|
|
ICU Transfer
大体时间：At discharge (an average of 14 days)
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Proportion of patients requiring transfer to the intensive care unit (ICU) during hospitalization (for admissions to non-ICU departments) or requiring repeated transfer to the ICU (if initially admitted to the ICU)
|
At discharge (an average of 14 days)
|
|
Mortality
大体时间：30 days after diagnosis
|
Probability of death within 30 days after diagnosis, estimated using the Kaplan-Meier method
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30 days after diagnosis
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月20日
初级完成 (估计的)
2027年2月4日
研究完成 (估计的)
2027年2月20日
研究注册日期
首次提交
2026年6月12日
首先提交符合 QC 标准的
2026年6月28日
首次发布 (实际的)
2026年7月2日
研究记录更新
最后更新发布 (实际的)
2026年7月2日
上次提交的符合 QC 标准的更新
2026年6月28日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他研究编号
- IE-2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
There is no current plan to share individual participant data (IPD) because data protection requirements and consent procedures for this study do not allow external data sharing beyond the study team.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.