Non-interventional Observational Study of Daptomycin in the Treatment of Gram-positive Bacterial Infections
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Clinical efficacy rate
研究概览
简要总结
This study aims to collect and analyze clinical data of daptomycin to explore the efficacy and safety of daptomycin in the treatment of Gram-positive bacterial infections. And optimize the dosing regimen based on these data.
详细描述
With the gradual increase in the detection rate of drug-resistant bacteria, bloodstream infections, skin and soft tissue infections, infective endocarditis and other infectious diseases caused by MRSA, MRCNS, and VRE have greatly increased patient mortality and medical burden.
Daptomycin has strong anti-bacterial activity and rapid sterilization. It is almost 100% sensitive to common Gram-positive bacteria. Both domestic and foreign guidelines recommend its use for the treatment of infectious diseases such as bacteremia, central venous catheter-related bloodstream infections, infective endocarditis, skin and soft tissue infections, bone and joint infections，and so on. However, there is a lack of actual clinical use of daptomycin in China, as well as efficacy and safety assessments based on real world data.
The purpose of this study is to collect and analyze data on the use of daptomycin in the real world. The clinical cure rate and inefficiency, temperature drop time, 28-day mortality rate are the primary outcome measures, and the overall incidence of adverse events, the results of CPK monitoring and its correlation with dose, renal function, length of hospital stay, and treatment costs are secondary outcome measures to investigate the efficacy and safety of daptomycin in the treatment of gram-positive bacterial infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 years of age or older
- •Meet one of the following conditions:
- •Confirmed Gram-positive cocci (GPC) infection;
- •Cases evaluated by doctors as suspected gram-positive coccal infection with potentially high benefit from drug use；
- •Severe infection patients to be combined with empirical treatment of daptomycin.
- •The off-label drug use conforms to the relevant administrative regulations of each participating unit.
排除标准
- •Allergic to datoramycin;
- •Pregnant and lactating women；
- •Patients with age < 1 year；
- •Participate in other clinical trials；
- •Patients with nervous system GPC infection;
- •Patients with pulmonary GPC infection.
研究组 & 干预措施
Gram-positive cocci infection
No intervention. The clinical data of patients (including demographic information, details of anti-infective therapy, imaging and laboratory testings) will be collected and analyzed.
干预措施: Daptomycin (Drug)
结局指标
主要结局
Clinical efficacy rate
时间窗: 1 day of the end of treatment
Clinical efficacy includes clinical cure and clinical improvement.
Treatment failure rate
时间窗: 28 days of the end of treatment
Treatment failure includes one of the following conditions: 1. After the end of the treatment, all the symptoms and signs of the patients at the time of inclusion continued or worsened. 2. Recurrence. 3. Termination of treatment due to adverse reactions.
28-Day Mortality Rate
时间窗: 28 days of the end of treatment
Record the number of deaths 28 days after the end of treatment
Clinical cure rate
时间窗: 14 days of the end of treatment
Clinical cure was defined as that after the end of treatment, all the selected symptoms and signs had disappeared or completely returned to normal, and all the non-microbiological indicators, such as imaging and laboratory examination, had returned to normal.
Time for body temperature to return to normal.
时间窗: 14 days of the end of treatment
During the use of daptomycin, take body temperature records.
次要结局
- The overall incidence of adverse events(14 days of the end of treatment)
- hospital stays(28 days of the end of treatment)
- Bacteria clearance rate (if available, such as bacteremia)(1 day of the end of treatment)
- Monitor creatine phosphokinase（CPK） levels(14 days of the end of treatment)