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

Intensive Care Unit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970537
• Other study ID #: 202105202
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Infection
• Intensive Care Unit
• Polymyxin B
• Tigecycline

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).