Patients with severe infection with carbapenem resistant gram-negative bacteria
Conditions
Interventions
Observation group (Enrolled patients were treated with ceftazidime for injection and avibactam sodium for at least 72 hours, and TDM intervention was performed):None
Sponsors
The First Affiliated Hospital of Nanchang Universit
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1 Males or females, aged 18 to 80 years (inclusive); 2 Critically ill patients; 3 Primary infection site specimens confirmed by bacterial culture to have at least one strain of Carbapenem-resistant Gram-negative pathogens sensitive to Ceftazidime-Avibactam (including but not limited to Carbapenem-resistant Enterobacteriaceae and/or Pseudomonas aeruginosa); 4 Sufficient respiratory secretions, blood, peritoneal fluid and other samples for bacterial culture and susceptibility testing can be obtained within 48 hours prior to the first dose; 5 Intravenous administration of Ceftazidime-Avibactam for >= 72 hours; 6 Individuals who understand and comply with the research procedures and methods, voluntarily participate in this study, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who have a history of allergy to ß-lactam antibacterial drugs, including cephalosporins, cephalosporins-containing ß-lactamase inhibitors, or ceftazidime avibactam sodium for injection and its excipients (2) Patients who are unable to collect blood samples after reaching steady state (24-48 hours after the first dose). (3) Patients with respiratory failure or irreversible myocardial dysfunction who require ECMO therapy (4) If the culture results of microorganisms within 72 hours before the first dose of administration can be obtained, and any of the following conditions exist: a. Infection caused by gram-positive bacteria without concomitant gram-negative bacteria infection (polymicrobial co-infection caused by gram-positive bacteria is allowed, provided that gram-negative bacteria are present and need to be treated); b. Patients with infections caused by gram-negative bacteria (such as Acinetobacter baumannii, refractory drug-resistant Pseudomonas aeruginosa, etc.) that are expected to have no response/low sensitivity rate to treatment with ceftazidime avibactam sodium for injection (if the investigator considers the strain to be a colonizing bacterium that does not require special treatment and meets other criteria, the patient can participate in this study); c. Patients with infections caused by gram-negative bacteria resistant to ceftazidime avibactam sodium for injection (if the enzyme type is detected as metalloenzyme, or confirmed by drug sensitivity, the investigator believes that ceftazidime avibactam combined with aztreonam can be treated, and meets other criteria, the patient can participate in this study); (5) Those who plan to use the prohibited drugs specified in the protocol during the study period (6) Known or suspected history of Clostridium difficile-associated diarrhoea (CDAD). (7) Positive human immunodeficiency virus (HIV) antibody. (8) Female patients who are currently pregnant or lactating (9) Any physical or psychological disease or condition that may increase the risk of the trial, affect the patient's compliance with the protocol, or affect the patient's completion of the trial, as judged by the investigator. (10) Staff members or their immediate family members participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine examination;Blood biochemistry;Hepatorenal function;Blood glucose;Electrolyte test;Blood clotting tests;Routine urine test;Stool routine; | — |
Countries
CHINA
Contacts
Public Contacthujinfang333@126.com
The First Affiliated Hospital of Nanchang Universit
Outcome results
None listed