2024-519969-21-00招募中4 期
Oral antimicrobial treatment vs. outpatient parenteral for infective endocarditis
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer9 个研究点 分布在 1 个国家目标入组 342 人开始时间: 2025年1月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 342
- 试验地点
- 9
- 主要终点
- Composite endpoint (whatever happen first) of unplanned hospitalization due to any reason, all-cause mortality, unplanned cardiac surgery and IE relapse within six months from diagnosis
研究概览
简要总结
To demonstrate the non-inferiority of outpatient oral antibiotic therapy in comparison with outpatient parenteral antibiotic treatment (OPAT)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant microorganisms: Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella and Abiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negative staphylococci and HACEK group.
- •Male or female 18 years old or older.
- •≥10 days of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after valve surgery
- •T<38.0° C for more than two days
- •C-reactive protein dropped below 25% of the peak value or below an absolute value of 20 mg/L, and the white blood cell count dropped to less than 15 × 10(9)/L during antibiotic treatment
- •No sign of abscess formation revealed by echocardiography
- •Transthoracic/transesophageal echocardiography performed preferably within 48 h of randomization. Ecoscopy or portable echocardiogram are also admitted, as long as they are registered on the clinical history.
排除标准
- •Body mass index >40
- •Women in lactancy period
- •Concomitant infection requiring intravenous antibiotic therapy
- •Inability to give informed consent to participation
- •Suspicion of reduced absorption of oral treatment due to abdominal disorder
- •Microorganisms other than those defined in inclusion criteria
- •Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy
- •No family or appropriate home support
- •Reduced compliance
- •Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period.
结局指标
主要结局
Composite endpoint (whatever happen first) of unplanned hospitalization due to any reason, all-cause mortality, unplanned cardiac surgery and IE relapse within six months from diagnosis
Composite endpoint (whatever happen first) of unplanned hospitalization due to any reason, all-cause mortality, unplanned cardiac surgery and IE relapse within six months from diagnosis
次要结局
- To evaluate quality of life and patient satisfaction
- To evaluate costs of both interventions through a pharmacoeconomic analysis.
- To evaluate number complications related to parenteral administration and oral administration of antibiotics (such as catheter related infections, Cl difficile diarrhea,among others).
- Unplanned hospitalization, all-cause mortality, unplanned cardiac surgery and relapse of IE rates for each variable
研究者
Dr. Guillermo Cuervo
Scientific
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
研究点 (9)
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