pulmonary infection
Conditions
Interventions
observation group:none
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-90 years old (including the threshold) 2. at least one carbapenem-resistant gram-negative pathogen (including but not limited to carbapenem-resistant Enterobacteriaceae and/or Pseudomonas aeruginosa) confirmed by bacterial culture of specimens collected from lung infections 3. subjects with confirmed carbapenem-resistant gram-negative pneumonia (HAP/VAP) 4. patients treated with ceftazidime injection and avibactam sodium for =3 days 5. patients who understand and comply with the study procedures and methods Understand and comply with the study procedures and methods, voluntarily participate in this trial, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Confirmed or suspected viral, fungal or parasitic pneumonia 2. Concomitant other lung disease that, in the judgement of the investigator, affects the assessment of efficacy, e.g., active tuberculosis, cystic fibrosis, pulmonary sarcoidosis, lung transplantation 3. Patients with an expected survival of less than 48 h. 4. Carbapenem-resistant Acinetobacter baumannii 5. Those who, in the opinion of the investigator, have other factors that make them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality on day 28 after drug initiation;Time from ceftazidime avibactam sodium use to clinical symptom improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy rate on day 14 after drug initiation;Microbiological clearance on day 14 after drug initiation;Mortality associated with pulmonary infection on day 28 after drug initiation;Hospitalisation mortality rate;Clinical efficacy rate on day 28 after drug initiation;Microbiological clearance on day 28 after initiation of dosing;Bacterial recurrence rate on day 28 after drug initiation;Bacteriological values on day 28 after the start of dosage.;Bacteria persisted on day 28 after the start of dosing.;Length of stay, length of stay in ICU;Proportion and number of days requiring organ function support (CRRT, mechanical ventilation, ECMO, artificial liver) within the 28th day of drug initiation;Adverse drug-related reactions to ceftazidime avibactam sodium during ICU stay (AKI, rash, cytopenia, CNS disturbances, gastrointestinal intolerance and C. difficile-associated diarrhoea); | — |
Countries
China
Contacts
Public ContactChen DeChang
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed