Prospective Registry and Biobank of Patients With Infectious Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Treatment of specific infectious diseases
研究概览
简要总结
Prospective observational study designed to describe the clinical, laboratory, imaging, microbiological characteristics and treatment of specific infectious diseases, with the addition of a dedicated biobank.
详细描述
The registry would provide a comprehensive database including a vast population of patients with infectious diseases, favoring the analysis of clinical, laboratory and therapeutic data of specific infectious conditions.
Specific infectious diseases of major interest include, among others:
- Bloodstream infections (i.e.: infectious syndromes manifesting with bacteremia)
- Endovascular infections (i.e.: infective endocarditis, cardiovascular implantable electronic device infections, vascular graft infections, etc.)
- Central nervous system infections (i.e.: meningitis, encephalitis, cerebral abscess, ventricular shunts infections, etc.)
- Bone and joint infections (i.e.: osteomyelitis, spondylodiscitis, prosthetic joint infections, etc.)
- Sexually transmitted infections (i.e.: gonococcal and non-gonococcal urethritis, proctitis, epididymo-orchitis, syphilis, etc.)
- HIV infection
- Emerging and re-emerging infectious diseases.
General objectives of the study for each specific infectious disease include:
- description and evolution over time of clinical and laboratory characteristics of patients with specific infectious diseases;
- description and evolution over time of microbial isolates, including antimicrobial susceptibility testing;
- description and evolution over time of treatment employed in patients with specific infectious diseases;
- evaluation of predictive factors for treatment success and mortality in patients with specific infectious diseases;
- description, evaluation and prognostic impact of microbial, immunological and inflammatory biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically suspected or microbiologically documented infectious diseases (bacterial, viral, fungal or parasitic);
- •At least 18 years of age or older;
- •Able to provide informed consent;
- •Participants who are unable to understand the study protocol or are unable to give informed consent, but have a legal representative
排除标准
- •- Participants who are unable to understand the study protocol or are unable to give informed consent, and have no legal representative.
结局指标
主要结局
Treatment of specific infectious diseases
时间窗: 6 months (with the exception of people living with HIV)
Describe the antimicrobial treatment of specific infectious diseases
Clinical characteristics of specific infectious diseases
时间窗: 6 months (with the exception of people living with HIV)
Describe the clinical presentation of specific infectious diseases, by means of Sequential Organ Failure Assessment (SOFA) score (minimum 0 - maximum 24; higher scores linked to worse outcome).
Microbiological characteristics of specific infectious diseases
时间窗: 6 months (with the exception of people living with HIV)
Describe the microbiological characteristics of specific infectious diseases. Specifically: * Identification of the causative organisms * Antimicrobial susceptibility testing results * Mechanism of resistance
次要结局
- Need for ICU(6 months (with the exception of people living with HIV))
- Overall mortality(6 months (with the exception of people living with HIV))
- Infection-attributable mortality(6 months (with the exception of people living with HIV))
- Predictive factors of microbiological cure(6 months (with the exception of people living with HIV))
- Predictive factors of clinical cure(6 months (with the exception of people living with HIV))
- Neurological impairment(6 months (with the exception of people living with HIV))
- Development of comorbidities(6 months (with the exception of people living with HIV))
- Need for surgical intervention or other procedures(6 months (with the exception of people living with HIV))
- Functional impairment(6 months (with the exception of people living with HIV))
- Development of drug toxicity(6 months (with the exception of people living with HIV))
研究者
Castagna Antonella
Full Professor
Ospedale San Raffaele