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临床试验/CTIS2023-508456-18-00
CTIS2023-508456-18-00进行中(未招募)1 期

Ramdomized non-inferiority clinical trial to evaluate the safety and efficacy of short duration therapy for non complicated enterococcal bacteremia. - INTENSE

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla0 个研究点目标入组 284 人开始时间: 2024年4月26日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
284

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • Adult patients (18 years or older) hospitalized with E. faecalis or E. faecium bacteremia., Negative control blood cultures performed between days 2-3 of treatment after the start of active treatment., Disappearance of fever (> 37.8ºC) in the first 72 hours., Signed informed consent

排除标准

  • Polymicrobial bacteremia., Patients with limited life expectancy in whom only conservative clinical management had been decided., Hemodynamic instability on day 5-6 after the start of active treatment., Patients wearing endovascular devices or heart valves prosthetics., Outbreak of uncontrolled bacteremia adequately defined as abscess not drained, bile duct infection associated with plastic prostheses not removed or not replaced within the first 72 hours of bacteremia, other infections related to unremoved prostheses, prostatitis, and endocarditis infectious, as well as infections that require prolonged treatment, such as joint and bone infections., Existence of a secondary focus, different from the initial focus or presence of metastatic focus of infection., Severe neutropenia (<500 cells / mm3) at the time of diagnosis of bacteremia, Pregnancy and lactation.

研究者

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