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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04970537
Other study ID # 202105202
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 23, 2017
Est. completion date July 31, 2021

Study information

Verified date August 2020
Source Xiangya Hospital of Central South University
Contact Shuangping Zhao
Phone 13974953002
Email zsping8888@sina.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Patients with treatment of less than 4 days; - patients with abscission; - Pregnant patients; - Patients with age < 14 years or > 95 years.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Xiangya Hospital of Central south university Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary hospital mortality rate Patients die in hospital or abandon treatment due to poor prognosis in hospital after treatment of tigecycline or polymyxin B up to hospital discharge or die in hospital, up to 48 weeks(estimation).
Primary 30d mortality rate Patients die after treatment of tigecycline or polymyxin B up to the 30th day of the treatment of tigecycline or polymyxin B
Primary Bacterial clearance rate Bacterial clearance during treatment of tigecycline or polymyxin B from the first day of the treatment of tigecycline or polymyxin B until to the end day, up to 8 weeks (estimation).
Secondary The length of hospital stay The length of hospital stay,days up to hospital discharge or die in hospital, up to 48 weeks (estimation).
Secondary The length of ICU stay The length of ICU stay up to hospital discharge or die in hospital, up to 24 weeks (estimation).
Secondary Hospitalization Cost total Hospitalization Cost up to hospital discharge or die in hospital, up to 48 weeks (estimation).
Secondary serum creatinine serum creatinine at the end day of the treatment of tigecycline or polymyxin B at the end day of the treatment of tigecycline or polymyxin B, up to 8 weeks (estimation).
Secondary MV days the total days with mechanical ventilation up to hospital discharge or die in hospital, up to 48 weeks (estimation).
Secondary VA days the total days with vasoactive agent up to hospital discharge or die in hospital, up to 48 weeks (estimation).
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