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

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.

Study Overview

• Status: Unknown
• Conditions: Intensive Care Unit; Polymyxin B; Tigecycline

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 Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Shuangping Zhao; Phone Number: 13974953002; Email: zsping8888@sina.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
      • Contact: Shuangping Zhao; Phone Number: 13974953002; Email: zsping8888@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

14-95 year-old patients in ICU, who received tigecycline and polymyxin B treatment (≥4d).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The length of hospital stay	The length of hospital stay,days	up to hospital discharge or die in hospital, up to 48 weeks (estimation).
The length of ICU stay	The length of ICU stay	up to hospital discharge or die in hospital, up to 24 weeks (estimation).
Hospitalization Cost	total Hospitalization Cost	up to hospital discharge or die in hospital, up to 48 weeks (estimation).
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).
MV days	the total days with mechanical ventilation	up to hospital discharge or die in hospital, up to 48 weeks (estimation).
VA days	the total days with vasoactive agent	up to hospital discharge or die in hospital, up to 48 weeks (estimation).

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Study Chair: Shuangping Zhao, Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2017
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2021

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 202105202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No