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

• Conditions: Intensive Care Unit; Polymyxin B; Tigecycline

• Registration Number: NCT04970537
• Lead Sponsor: Xiangya Hospital of Central South University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-07-23
• Status Verified: 2020-08
• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-19
• Last Update Submitted: 2021-07-19
• Study First Posted: 2021-07-21
• Last Update Posted: 2021-07-21
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hospital mortality rate	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	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	up to the 30th day of the treatment of tigecycline or polymyxin B	Patients die after treatment of tigecycline or polymyxin B

Secondary Outcome Measures

Name	Time	Method
The length of ICU stay	up to hospital discharge or die in hospital, up to 24 weeks (estimation).	The length of ICU stay
VA days	up to hospital discharge or die in hospital, up to 48 weeks (estimation).	the total days with vasoactive agent
Hospitalization Cost	up to hospital discharge or die in hospital, up to 48 weeks (estimation).	total Hospitalization Cost
The length of hospital stay	up to hospital discharge or die in hospital, up to 48 weeks (estimation).	The length of hospital stay,days
serum creatinine	at the end day of the treatment of tigecycline or polymyxin B, up to 8 weeks (estimation).	serum creatinine at the end day of the treatment of tigecycline or polymyxin B
MV days	up to hospital discharge or die in hospital, up to 48 weeks (estimation).	the total days with mechanical ventilation

Trial Locations

Locations (1)

Xiangya Hospital of Central south university; 🇨🇳 Changsha, Hunan, China