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

NCT04970537 | Unknown

• 1 other identifier: 202105202
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Tigecycline; Polymyxin B; Intensive Care Unit

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• The length of hospital stay

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

• The length of ICU stay

  up to hospital discharge or die in hospital, up to 24 weeks (estimation).

• Hospitalization Cost

  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).

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central south university

Changsha, Hunan, China

RECRUITING

Study Officials

• Shuangping Zhao

  Xiangya Hospital of Central South University

  STUDY CHAIR

Central Study Contacts

Shuangping Zhao

CONTACT

13974953002; zsping8888@sina.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 21, 2021
• Study Start: July 23, 2017
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: July 21, 2021

Record last verified: 2020-08

Locations

CN (1)