EUCTR2019-003358-10-ES进行中（未招募）1 期
Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial
Carmen Olmos Blanco0 个研究点目标入组 298 人开始时间: 2019年11月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 298
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
入选标准
- •Definite IE, according to modified ESC 2015 criteria, caused by gram-positive cocci (staphylococci, streptococci and enterococci), including native, prosthetic valve IE and cardiac device-related IE.
- •I8 years old or older.
- •Absence of fever, microbiological or analytical findings suggesting persistent infection after 24h of randomization.
- •Absence of locally uncontrolled infection signs (abscess, pseudoaneurysm, fistula, enlarging vegetation) at randomization, confirmed by recent transesophageal echocardiography (performed within 48 h of randomization).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 204
排除标准
- •Patients who recived more than 12 days of target antibiotic treatament to infective endocarditis
- •Patients not suitable to be discharged after randomization, due to clinical reasons (sequels of stroke that prevent discharge, progressive renal failure, hepatic failure).
- •Patients with immunosuppressive therapy or chemotherapy
- •Pregnant and breastfeeding women.
- •Need of prolonged antibiotic therapy due to spondylodiscitis.
- •Absence of patient’s ability or commitment to continue follow-up after being discharged from hospital.
- •Inability to give informed consent to participation.
- •Cognitive impairment or Spanish unknowledge
- •Patients candidate to cardiac surgery considered unoperable due to high surgical risk.
研究者
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