2023-508456-18-00尚未招募4 期
Ramdomized non-inferiority clinical trial to evaluate the safety and efficacy of short duration therapy for non complicated enterococcal bacteremia.
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla, Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla24 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2024年4月29日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 284
- 试验地点
- 24
- 主要终点
- Clinical success at TOC in the ITTP.
研究概览
简要总结
To demonstrate the non-inferiority of a 7-day antibiotic treatment regimen compared to a 14-day regimen in the treatment of uncomplicated enterococcal bacteremia, in terms of efficacy.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
- 分配方式
- Randomized
- 主要目的
- Clinical trial to evaluate safety and efficacy of a 7 vs 14-day treatment for enterococcal infection
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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.
结局指标
主要结局
Clinical success at TOC in the ITTP.
Clinical success at TOC in the ITTP.
次要结局
- Rates of diagnosis of relapse or infective endocarditis in OCD and follow-up visit in the clinically evaluable population (CEP).
- Survival in OCD and follow-up visit.
- Length of hospital stay
- Duration of IV and total therapy in CEP
- Infection with C. difficile.
- Adverse events and severity
- Secondary infections
- Change in SOFA score in OCD and follow-up visit.
研究者
Unidad de Investigación Clínica y ensayos clínicos UICEC HUVR
Scientific
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
研究点 (24)
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