Clinical trial NCT04970537: Efficacy Analysis of Tigecycline-based Therapy and Polymyxin B-based Therapy in ICU Infection
Official title: Efficacy Analysis of Tigecycline-based Therapy and Polymyxin B-based Therapy in ICU Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tigecycline
Polymyxin B
Intensive Care Unit
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 14-95 year-old patients in ICU, who received tigecycline and polymyxin B treatment (≥4d).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: hospital mortality rate
timeFrame: up to hospital discharge or die in hospital, up to 48 weeks(estimation).
measure: 30d mortality rate
timeFrame: up to the 30th day of the treatment of tigecycline or polymyxin B
measure: Bacterial clearance rate
timeFrame: from the first day of the treatment of tigecycline or polymyxin B until to the end day, up to 8 weeks (estimation).
Secondary outcomes:
measure: The length of hospital stay
timeFrame: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
measure: The length of ICU stay
timeFrame: up to hospital discharge or die in hospital, up to 24 weeks (estimation).
measure: Hospitalization Cost
timeFrame: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
measure: serum creatinine
timeFrame: at the end day of the treatment of tigecycline or polymyxin B, up to 8 weeks (estimation).
measure: MV days
timeFrame: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
measure: VA days
timeFrame: up to hospital discharge or die in hospital, up to 48 weeks (estimation).
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central south university
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Shuangping Zhao
role: STUDY_CHAIR
References: