Sepsis
Conditions
Interventions
Eravacycline group:None
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older (inclusive). 2.With confirmed infection, including bloodstream infection, pulmonary infection, intra-abdominal infection, and skin and soft tissue infection. 3.Meeting the diagnostic criteria for sepsis or septic shock as defined by Sepsis 3.0; (Sepsis diagnostic criteria: For patients with confirmed or suspected infection, sepsis is diagnosed when the Sepsis-related Organ Failure Assessment (SOFA) score increases by >2 points from baseline (baseline set as 0). 4.Pathogenic microorganisms identified as CR-GNB through methods including microbial culture and Next Generation Sequencing (NGS). 5.Receiving eravacycline or an eravacycline-based antibacterial treatment regimen. 6.The participant or legal representative has signed the Informed Consent Form (ICF).
Exclusion criteria
Exclusion criteria: 1.Aged under 18 years old; 2.Pregnant or lactating; 3.Any medical history, current condition, treatment, laboratory abnormality, or other circumstances that, in the investigator's opinion, may affect trial results, interrupt the trial process, or increase the risk of the subject using the study drug. 4.Rapidly progressive diseases or immediately life-threatening conditions, including acute liver failure, cardiogenic shock, severe arrhythmia, thyroid storm, etc.; 5.Patients with a history of allergic reactions to tetracyclines or any excipients in the study drug formulation; 6.The pathogen is Pseudomonas aeruginosa alone; 7.Patients with complicated urinary tract infections; 8.Other circumstances where the treating physician deems it inappropriate for the subject to enter the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sequential Organ Failure Assessment (SOFA) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality; | — |
Countries
China
Contacts
Public ContactSun Tongwen
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed