Carbapenem resistant Gram negative bacterial pulmonary infection
Conditions
Interventions
Non-exposed group (Traditional treatment plan group):None
Exposome group (Ceftazidime and Avibactam Sodium for Injection and Sodium Chloride Injection):None
Sponsors
Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with carbapenem resistant Gram-negative bacterial pulmonary infection: Chest X-ray or CT showing new or progressive infiltrates, consolidations, or ground glass opacities, combined with two or more of the following three clinical symptoms, can establish a clinical diagnosis: (1) fever, body temperature >38°C; (2) purulent airway secretions; (3) peripheral blood white blood cell count >10 × 10^9/L or 25/low magnification field, epithelial cell count 2.5:1), pathogenic bacteria cultured through bronchoscopy anti-contamination brush (PSB), bronchoalveolar lavage fluid (BALF), lung tissue or non-bacterial fluid, and consistent with clinical manifestations. Cultivate carbapenem resistant Gram-negative pathogens (CRE and/or CRPA), which are dominant bacteria (semi-quantitative >=+++ or quantitative culture >=10^4 CFU/mL), and the drug sensitivity results comply with the resistance inflection point of imipenem or meropenem in the current version of CLSI/EUCAST. 3. 18 years old <= age <= 85 years old, gender not limited. 4. Acute Physiology and Chronic Health Status Score (APACHE-II Score) <= 25 points. 5. Understand and comply with the research procedures and methods, voluntarily participate in this trial, and obtain written informed consent from the subjects or their families before enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients with an expected survival time of less than 72 hours. 2. Individuals with a history of allergies to beta-lactam antibiotics, including cephalosporins, cephalosporin complex preparations containing beta-lactam enzyme inhibitors, or injectable ceftazidime-avibactam sodium and its excipients; Individuals with a history of allergies to carbapenems, polymyxin B, tigecycline, tranexamic acid, etc.; Individuals with allergies. 3. The baseline infection pathogen is carbapenem resistant Acinetobacter baumannii (CRAB) as the main pathogen, or CRAB is identified as a pathogen requiring targeted treatment in mixed infections. 4. Individuals who have received effective treatment for CRE/CRP (such as polymyxin and tigecycline) for more than 24 hours within 72 hours prior to enrollment and have a good clinical response; During the study, potent CYP3A4 inducers (such as rifampicin) should be used unless assessed by the investigator as necessary treatment and medication details recorded. 5. According to the researchers' assessment, patients with other lung diseases that affect the efficacy evaluation, such as active tuberculosis, pulmonary cystic fibrosis, pulmonary granulomatous disease, lung transplantation, primary lung cancer (including small cell lung cancer/non-small cell lung cancer), or other malignant tumors that have metastasized to the lungs or other known bronchial blockages, have been diagnosed. 6. Patients with abnormal liver function tests: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 5 times the upper limit of the reference value, and total bilirubin or direct bilirubin >= 2 times the upper limit of the reference value, or Child-Pugh C-grade patients. 7. Individuals with any known serious diseases that affect the immune system, such as a history of human immunodeficiency virus (HIV) infection; or malignant tumors of the advanced hematological system; or splenectomy, etc. 8. Researchers believe that patients with any other factors that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs and laboratory tests;Occurrence of adverse events;Exploratory indicators;Duration of mechanical ventilation and degree of dependence on ventilators;Improvement of inflammatory indicators;Microbiological clearance rate;ICU stay time; | — |
Countries
China
Contacts
Public ContactLong Kunlan
Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed