Clinical Efficacy and Safety
Conditions
Keywords
Eravacycline, Tigecycline, Gram-negative bacteria, adverse drug reactions
Brief summary
A multicenter, retrospective, real-world stduy . Subjects with composite criteria were teated with eravacycline ,and 100 cases ,Tigecycline and 300 cases were to be enrolled.
Detailed description
The study is a multicenter, retrospective, real-world study, through retrospective collection of cases of gram-negative bacterial infections in the First Affiliated Hospital of Nanjing Medical University, Nanjing Drum Tower Hospital, Nanjing First Hospital, Shaw Hospital Affiliated to Nanjing Medical University, Affiliated Hospital of Xuzhou Medical University, and Xuzhou Central Hospital, and 100 cases of eravacycline,300 cases of tigecycline are planned to be enrolled. Inclusion Criteria: Bacteriological results show drug-resistant Gram-negative bacteria Use of new tetracycline drugs for ≥72 hours Age ≥18 years Exclusion Criteria: Advanced tumors Severe immunodeficiency or mental illness Severe liver and kidney dysfunction Pregnant or breastfeeding women Rejection Criteria: None Data acquisition: General condition: age, gender, acute physiology and chronic health status score (APACHEII), endotracheal intubation/tracheostomy, site of infection, course of treatment, presence of other pathogens, concomitant use of other antibiotics, and ICU admission; Specimen source: blood/respiratory/other; Drug-resistant pathogens: Acinetobacter baumannii/Klebsiella pneumoniae/Escherichia coli; Evaluation of clinical efficacy and bacterial efficacy during treatment with eravacycline and tigecycline; Common adverse reactions in eravacycline or tigecycline therapy; Treatment options Recommended dose of eravacycline : calculated according to the patient's weight, intravenous infusion at 1mg/kg, q12h, the infusion duration is not less than 60 minutes, and the recommended course of treatment is 4-14 days. The investigator can adjust the specific medication regimen according to the severity and location of the patient's infection and the patient's clinical response. Recommended dose of tigecycline is 100 mg as a loading dose and 50 mg every 12 hours as a maintenance dose, and for multidrug-resistant infections, a high-dose tigecycline 200 mg as an initial dose and a maintenance dose up to 100 mg every 12 hours.
Interventions
DRUGbronchoscope
We will perform bronchoscopy and collect bronchoalveolar lavage fluid(BALF)
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Bacteriological results show drug-resistant Gram-negative bacteria Use of new tetracycline drugs for ≥72 hours Age ≥18 years
Exclusion criteria
Advanced tumors Severe immunodeficiency or mental illness Severe liver and kidney dysfunction Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy | 14 days | The main outcome is the clinical results of assessed by clinical physicians, where clinical outcomes are recorded as successful or unsuccessful, defined by the relief of clinical symptoms, which is defined as imaging improvement determined by the clinician, normalization or significant reduction of white blood cell counts and related inflammatory indicators including CRP, PCT, IL-6, etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological efficacy and safety | 14 days | The secondary outcome is the microbiological efficacy, namely the control of bacterial infections during hospitalization (including the clearance and partial clearance of bacteria) and safety, which is assessed by evaluating the incidence of adverse events and changes in clinical laboratory test results (including liver and kidney functions, coagulation function, etc.) for all study subjects. |
Countries
China
Outcome results
None listed