A Prospective,Multicenter,Non-interventional Real-world Study for Standardized Clinical Application of Antibacterial/Anitifungal Drugs
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 主要终点
- Proportion of standardized using of antibacterial/antifungal drugs
研究概览
简要总结
The purpose of this real world study is to observe the clinical status for standardized using of antibacterial/anitifungal drugs in patients with infection,and to evaluate the efficacy and safety of anti-infection therapy.
详细描述
This study is a prospective,multicenter,non-interventional real-world study.The purpose of this study is to observe the clinical status of infection patients under standardized application of antibacterial/anitifungal drugs,and to evaluate the efficacy and safety of anti-infection treatment.
This study plans to enroll 5000 hospitalized patients (≥ 18 years old with infectious disease),who take antibacterial/anitifungal drugs for more than 3 days. Patients mainly come from ICU,Respiratory Department and Hematology Department.
The clinical data collection is divided into five parts,including Baseline,3rd and 7th day after the first dosing of antibacterial/anitifungal drugs,End of antibacterial/anitifungal drugs treatment (EOT),14th day after EOT. The collected clinical data cover general characteristics,condition assessment and severity evaluation,pathogenic diagnosis,the use of antibacterial/antifungal drugs,antibacterial/antifungal drugs-related adverse events,et al.
After completing the collection of case data, the proportion analysis, efficacy evaluation and safety evaluation for the standardized application of antibacterial/antifungal drugs will be carried out.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Hospitalized patients (≥ 18 years old)
- •≥ 3 days receiving antibacterial/antifungal drugs therapy
排除标准
- 未提供
结局指标
主要结局
Proportion of standardized using of antibacterial/antifungal drugs
时间窗: approximately 6 months after completion of data collection
the proportion of cases who receive standardized antibacterial/antifungal drugs therapy
Clinical efficacy rate
时间窗: approximately 6 months after completion of data collection
the clinical efficacy evaluation of antibacterial/antifungal drugs therapy
次要结局
- Microbiological efficacy rate(approximately 6 months after completion of data collection)
- Overall efficacy rate(approximately 6 months after completion of data collection)
- All-cause mortality(approximately 6 months after completion of data collection)
- Antibacterial/antifungal drugs-Related Adverse Events(approximately 6 months after completion of data collection)
研究者
An Youzhong
Director of intensive care unit
Peking University People's Hospital