Central Nervous System Infection
Conditions
Interventions
Group 1:Intravenous infusion of ceftazidime avibatan
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Before the start of the study, the patients or their legal representatives voluntarily sign an informed consent form approved by the ethics committee; 2. Age 18 to 80 years old, male or female; 3. Patients after neurosurgery; 4. Hospitalized patients with clinical diagnosis of bacterial meningitis/ventriculitis, and the results of cerebrospinal fluid culture are carbamate-resistant gram-negative bacteria (except Acinetobacter, Stenotrophomonas and Metalloenzyme) ; (See appendix 1 for the basis of diagnosis of bacterial meningitis/ventriculitis) 5. Those who need continuous drainage of cerebrospinal fluid due to illness (including external ventricular drainage or lumbar cistern drainage, etc.); 6. Patients who have received antibacterial treatment for more than 48 hours before enrollment, but the symptoms and signs of infection are not relieved, and the cerebrospinal fluid culture is still positive can also be enrolled.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy to the active substance or any of the excipients listed in the [ingredients] item, cephalosporin antibiotics, other types of ß-lactam antibiotics (such as penicillin, monoamidocin or carbapenem) ) and other severe hypersensitivity; 2. Unstable vital signs or inability to collect cerebrospinal fluid samples; 3. It is estimated that the Ommaya capsule and other devices cannot be removed or replaced during the entire treatment process and need to be permanently indwelled; 4. Status epilepticus that cannot be controlled by drugs, or psychiatric disorders that may affect program compliance, or persons at risk of suicide; 5. Those with a history of alcohol abuse; 6. Those with a history of drug abuse; 7. Cerebrospinal fluid culture of simple Gram-positive bacteria, Acinetobacter, Stenotrophomonas, Metalloenzyme; 8. Acute active infection in any other part; 9. Patients with moderate or severe renal impairment, that is, endogenous creatinine clearance (CrCL) = 5 times the upper limit of the reference value 3 days before enrollment, and total bilirubin or direct bilirubin >= 3 days before enrollment 2 times the upper limit of the reference value; 11. Anyone with any known disease that seriously affects the immune system, such as: history of human immunodeficiency virus (HIV) infection; or advanced hematological malignancies; or splenectomy; 12. Female pregnancy (urine pregnancy); test positive), lactating patients; 13. The investigator believes that there may be any circumstances that may increase the risk of patients or interfere with clinical research; 14. Patients who have participated in this clinical study and used the study drug before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug concentration in plasma;Drug concentration in cerebrospinal fluid;Early clinical response;Early clinical response;Laboratory examination;Vital signs;Physical examination;Adverse effect; | — |
Countries
China
Contacts
Public ContactMao Ying, Zhang Jing
Neurosurgery Department,Phase I Clinical Research Center
Outcome results
None listed