NCT05880069Enrolling By Invitation不适用
Clinical Outcomes in Patients With Infection by Resistant Microorganism
Hospital Universitario Virgen Macarena1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The goal of this individual patient data meta-analysis is to estimate the attributed and the associated health burden related to bloodstream infections, pneumonia, skin and soft tissue infections, surgical site infections and urinary tract infections, caused by target drug-resistant pathogens, in high income countries.
The main question[s] it aims to answer are:
- Are common infections caused by drug-resistant pathogens associated with an increased health burden, when compared with individuals with the same infection caused by a susceptible strain (attributed burden)?
- Are common infections caused by drug-resistant pathogens associated with an increase health burden, when compared with individuals without the infection under study (associated burden)?
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of all ages
- •Individuals with hospital acquired, community acquired, or healthcare associated infections
- •Individuals treated at hospital level, community, or long-term care facilities
- •Individuals with the targeted pathogen, resistance phenotype, and infection site combinations under study
排除标准
- •Individuals with infections in the following systems: central nervous system, genital system, pelvic infections and head and neck infections
- •Individuals with the following specific primary infections: endocarditis, upper respiratory tract infections, lung abscess
- •Individuals with bacterial infections not included in the table of pathogens of interest, polymicrobial infections except for intraabdominal infections, fungal infections, parasitic infections, viral infections, mycobacterial infections, sexually transmitted diseases, and zoonotic infections
结局指标
主要结局
Mortality
时间窗: Through study completion, an average of 1 year
Death any time after infection, during the follow-up time of the original study.
次要结局
- Number of participants with ICU admission(Through study completion, an average of 1 year)
- Number of participants with recurrence of infection(Through study completion, an average of 1 year)
- Number of participants with cognitive impairment / disability(Through study completion, an average of 1 year)
- Number of participants with superinfection(Through study completion, an average of 1 year)
- Number of participants with clinical cure(Through study completion, an average of 1 year)
- Number of participants with microbiological cure(Through study completion, an average of 1 year)
研究者
研究点 (1)
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