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临床试验/NCT05144399
NCT05144399进行中(未招募)不适用

Accelerated Treatment of Endocarditis

Herlev Hospital14 个研究点 分布在 3 个国家目标入组 508 人开始时间: 2019年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
508
试验地点
14
主要终点
Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery

研究概览

简要总结

Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks one or more types of intravenously administered antibiotics. The long hospitalization increases several risks for the patient, including mental strain and increased loss of function. Furthermore, it poses a significant financial burden on the health systems. Current guidelines fail to use available clinical and paraclinical, data collected from patients (echo, temperature, CRP, leukocytes, procalcitonin etc.) to determine duration of treatment. A strategy including these data in treatment algorithms ensures an individualized treatment, targeting the individual patient's course and response to treatment. Thus, the purpose of this open-label, prospective, non-inferiority, RCT study is to investigate the safety and effectiveness of shortening treatment of endocarditis based on the individual patient's initial treatment response, sampling 475 patients, approx. 125 patients with each type of bacteria (Streptococci; Enterococcus faecalis; Staphylococcus aureus). Interim analysis will be conducted when 150 patients have been included, to assess the frequency of the event rate and inclusion rate in order to adjust the intended size of the study population.

Due to an administrative error, this study has been registered twice on clinicaltrials.gov under identifiers NCT05144399 (original) and NCT03851575 (duplicate). As per July 2026, both records have been updated to unanimously reflect study status and final protocol. Historical versions of the clinicaltrials.gov registration and updates are available under the respective registration ID's (2018-2020 updates under clinicaltrials.gov registration with ID NCT05144399, 2021-2026 updates clinicaltrials.gov registration with ID NCT03851575).

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

入选标准

  • Patients hospitalized and diagnosed with bacterial, left-sided endocarditis as determined by the department clinician responsible based on the revised Duke criteria.
  • The patient may be included <14 days after beginning of relevant antibiotic treatment.
  • Left-sided endocarditis with one of the following microorganisms: Streptococci; Enterococcus faecalis; Staphylococcus aureus.
  • Patients ≥ 18 years.

排除标准

  • Known / suspected immunocompetence (HIV, chemotherapy, prednisolone treatment (> 20 mg / day)).
  • Incapability to give informed consent for participation.
  • Relapse Endocarditis (Endocarditis with the same bacteria within six months).

研究组 & 干预措施

Accelerated antibiotic treatment

Experimental

Patients are treated shorter than usual

干预措施: Accelerated antibiotic treatment (Other)

Standard length of antibiotic treatment

Other

Patients are receiving the standard length of antibiotic treatment

干预措施: Standard treatment length (Other)

结局指标

主要结局

Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery

时间窗: 6 months after randomization

The primary endpoint is a combined endpoint consisting of the following events occurring within six months after the earliest time of potential treatment discontinuation: Death; Embolisms; Heart surgery not planned at the time of randomization.

Primary efficacy endpoint: Difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups

时间窗: 6 months after randomization

The primary efficacy endpoint is the difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups, assessed from and until 6 months after randomization.

次要结局

  • Duration of admission(6 months after randomization)
  • Duration of antibiotic treatment(6 months after randomization)
  • Frequency of catheter complication(6 months after randomization)
  • Unplanned Heart surgery(6 months after randomization)
  • Expenses associated with admission and treatment(6 months after randomization)
  • Embolic events(6 months after randomization)
  • Re-bacteremia with the primary pathogen(6 months after randomization)
  • All cause mortality(6 months after randomization)
  • Quality of life assesment(6 monts after randomization and after)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kasper Iversen

Professor

Herlev Hospital

研究点 (14)

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