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临床试验/NCT04970537
NCT04970537Unknown不适用

Efficacy Analysis of Tigecycline-based Therapy and Polymyxin B-based Therapy in ICU Infection

Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2017年7月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
800
试验地点
1
主要终点
hospital mortality rate

研究概览

简要总结

The gender, age, ICU diagnosis, basic diseases, antibiotic treatment plan, physiological indicators, duration of hospital stay, length of stay in ICU, hospitalization cost, prognosis and other discharge information of patients receiving tigecycline or polymyxin B admitted to the ICU of four provincial-level Grade A hospitals in Changsha, Hunan Province ,China from 2017 to 2021 were included.

To analyze the therapeutic effect of tigecycline-based or polymyxin B-based antibiotic regimens and their effect on the prognosis of patients, and to conduct subgroup analysis.

详细描述

The gender, age, ICU diagnosis, basic diseases, antibiotic treatment plan, physiological indicators, duration of hospital stay, length of stay in ICU, hospitalization cost, prognosis and other discharge information of patients receiving tigecycline or polymyxin B admitted to the ICU of four provincial-level Grade A hospitals in Changsha, Hunan Province ,China from 2017 to 2021 were included. The four hospitals included the 1st-3th XiangYa Hospitals and Hunan Provincial People's Hospital. Organize the data.Patients with a course of treatment < 4 days and shedding were excluded.To analyze the therapeutic effect of tigecycline-based or polymyxin B-based antibiotic regimens and their effect on the prognosis of patients, and to conduct subgroup analysis. The chi-square test was used for the counting data, and the Mann-Whitney U test or Kruskal-Wallis H test was used for the measurement data. The significance value was adjusted by Bonferroni correction method for multiple tests, and the P was tested on both sides,P>0.05.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ICU patients receiving tigecycline or polymyxin B treatment;
  • Age 14-95, gender unlimited;
  • there are clear infections and strains;
  • The patient and/or his/her family agree to sign the informed consent voluntarily.

排除标准

  • Patients with treatment of less than 4 days;
  • patients with abscission;
  • Pregnant patients;
  • Patients with age < 14 years or > 95 years.

结局指标

主要结局

hospital mortality rate

时间窗: up to hospital discharge or die in hospital, up to 48 weeks(estimation).

Patients die in hospital or abandon treatment due to poor prognosis in hospital after treatment of tigecycline or polymyxin B

Bacterial clearance rate

时间窗: from the first day of the treatment of tigecycline or polymyxin B until to the end day, up to 8 weeks (estimation).

Bacterial clearance during treatment of tigecycline or polymyxin B

30d mortality rate

时间窗: up to the 30th day of the treatment of tigecycline or polymyxin B

Patients die after treatment of tigecycline or polymyxin B

次要结局

  • The length of ICU stay(up to hospital discharge or die in hospital, up to 24 weeks (estimation).)
  • VA days(up to hospital discharge or die in hospital, up to 48 weeks (estimation).)
  • Hospitalization Cost(up to hospital discharge or die in hospital, up to 48 weeks (estimation).)
  • The length of hospital stay(up to hospital discharge or die in hospital, up to 48 weeks (estimation).)
  • serum creatinine(at the end day of the treatment of tigecycline or polymyxin B, up to 8 weeks (estimation).)
  • MV days(up to hospital discharge or die in hospital, up to 48 weeks (estimation).)

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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