Central Nervous System Infection
Conditions
Interventions
Group one:Ceftazidime/avibactam sodium combined with polymyxin B (intrathecal injection)
Group two:Meropenem combined with polymyxin B (systematic and intrathecal injection)
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Evidence of a personally signed and dated informed document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study which is approved by ethics committee prior to study procedures; 2. Male or female between the ages of 18 and 80 years; 3. Hospitalized patients with a diagnosis of bacterial meningitis/ventriculitis will be enrolled. And cerebrospinal fluid (CSF) culture reveales carbapenem-resistant Gram-negative bacteria (except for Acinetobacter Stenotrophomonas and Metallo-ß-lactamases-producing bacteria); (the diagnosis of bacterial meningitis/ventriculitis see Appendix 1 for details); 4. Patients with continuous cerebrospinal fluid drainage due to illness (including extraventricular drainage or lumbar drainage,etc); 5. Time of systemic antibiotic treatment is no more than 48h prior to enrollment. If the antibiotic treatment exceeds 48h, while there is no relief in infection symptom and sign, and culture of CSF is still positive, the patient could be enrolled.
Exclusion criteria
Exclusion criteria: 1. Patients with documented or suspected history of hypersensitivity or allergic reaction to the active substances or any excipients listed in the component, or with severe hypersensitivity to cephalosporins or other ß-lactam antimicrobials (such as penicillins, monobactams or carbapenems,etc.); 2. Unstable vital signs or unable to obtain CSF specimen; 3. Indwelling devices such as ommaya are estimated to be not able to remove or replace during the study period; 4. Patients with status epilepticus which cannot be controlled by drugs, or mental disorders which may influence patients compliance to study, or with suicide risks; 5. History of alcohol abuse; 6. History of drug abuse; 7. The cultur e of CSF specimen showed Gram-positive bacterial only, Acinetobacter ,Stenotrophomonas or Metallo-ß-lactamases-producing bacteria; 8. Patients with moderate or severe renal insufficiency, defined as creatinine clearance (CrCL) = five times the upper reference limit, and total bilirubin or direct bilirubin >= two times the upper reference limit within three days before screening; 10. Patients with any known diseases which have a serious impact on the immune system, such as a history of human immunodeficiency virus (HIV) infection, progressive hematological malignancy, or splenectomy,etc; 11. Patient is pregnant (positive urine pregnancy test) or lactating; 12. Investigator judges the risks and intervene to the study; 13. Patients who have participated in this study and have 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 microbiological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory examination;Vital signs;Physical examination;Adverse effect; | — |
Countries
China
Contacts
Public ContactNanyang Li
Phase I Clinical Research Office of Huashan Hospital, Fudan University
Outcome results
None listed