Acinetobacter Baumannii, Pneumonia, Bacterial, Pulmonary Infection
Conditions
Keywords
Eravacyline
Brief summary
The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety. Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time
Interventions
DRUGEravacycline Injection
Eravacycline at the recommended dose and administration method according to the instructions: 1 mg/kg intravenous administration, every 12 hours. The intravenous infusion duration is approximately 60 minutes. For patients with severe liver impairment (Child-Pugh class C), administer 1 mg/kg of this product every 12 hours on the first day, followed by 1 mg/kg every 24 hours starting from the second day.
Sponsors
Fujian Medical University Union Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old; 2. Meets the diagnostic criteria for pneumonia specified by the Chinese Medical Association Respiratory Branch. 3. CRAB is identified or predominant pathogenic bacteria, and drug sensitivity test indicates that Eravacycline is sensitive to the strain; 4. Patients expected to receive Eravacycline for ≥4 days; 5. Has already signed the informed consent
Exclusion criteria
1. Pregnant or lactating; 2. Concurrent intracranial infection, urinary tract infection, or bloodstream infection; 3. Individuals in a moribund state; 4. The investigator believes there is any medical history, current condition, treatment, laboratory abnormalities, or other circumstances that may affect the trial results, interrupt the trial process (or the subject's inability to complete all trial requirements, operations, and visits), or increase the subject's risk with the experimental medication. Patients with terminal illnesses or evidence of immediately life-threatening diseases are excluded; 5. Patients with a history of allergic reactions to tetracyclines or any excipients in the investigational drug formulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Responded Rate | 28 days | Complete the treatment, and meet one of the following criteria to be considered clinical respond: 1. Patient's oxygenation index is stable or improved; 2. Patients with a SOFA score \<3 remain unchanged or decrease, and patients with a SOFA score ≥3 decrease by at least 30%; 3. Normal body temperature for more than 3 days; 4. Improvement in pulmonary imaging; 5. Infection indicators show a continuous downward trend for 3 consecutive day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The microbiological clearance rate | within 14days | The microbiological clearance rate at the end of treatment |
| The all-cause mortality rate within 28 days | 28 days | The all-cause mortality rate within 28 days |
| Incidence Rate of Adverse Event | 28days | safety data according to CTC-AE |
Countries
China
Contacts
Primary ContactHui Zhang, PhD
Outcome results
None listed