Central nervous system infections after neurosurgery
Conditions
Interventions
Experimental group:linezoid 600mg ivdrip q12h
meropenem 2g ivdrip q8h
control group:Vancomycin 1g ivdrip q12h
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 ~ 65 years old. 2. At least one neurosurgical craniotomy (including extraventricular drainage and hematoma puncture drainage) was performed and bacterial meningitis / ventriculitis occurred within 30 days after neurosurgery. 3. According to the diagnostic criteria of "Chinese expert consensus on diagnosis and treatment of severe infection in Neurosurgical patients (2017)", the clinical diagnosis of bacterial meningitis or ventriculitis should meet the following diagnostic criteria: (1) the presence of clinically suspected positive signs or symptoms, including fever (> 38 degrees C), headache, neck strength, meningeal irritation, signs of cranial nerve damage, changes in consciousness or mental state, at least one abnormal manifestation. (2) routine examination of cerebrospinal fluid showed that white blood cell count was >= 1000 / µ L, of which more than 75% were neutrophils, with or without increased protein content in cerebrospinal fluid or / and decreased sugar content in cerebrospinal fluid (< 2.5 mmol / L, or the ratio to blood glucose < 0.4). (3) Gram-positive bacteria were found in cerebrospinal fluid smears, or Gram-positive bacteria were cultured in cerebrospinal fluid and sensitive to linezolid or vancomycin. 4. the patient or his legal representative agrees to participate in the trial and sign the relevant informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients have central nervous system infection before craniotomy, including bacterial, fungal, viral or protobiological infection. 2. Gram-positive bacteria were found in cerebrospinal fluid smears, but cerebrospinal fluid culture, or extraventricular drainage and ventricular shunt tube head culture were not sensitive or resistant to linezolid. 3. Patients with high clinical suspicion or etiological diagnosis have central nervous system infection caused by other or multiple microorganisms other than Gram-positive bacteria. 4. The patient is known to be allergic to linezolid or similar drugs. 5. Thrombocytopenia existed before treatment. 6. Female patients during pregnancy or lactation. 7. Within 6 months before enrollment, patients are participating in or have participated in other interventional clinical studies. 8. Patients with renal insufficiency before admission and the estimated endogenous creatinine clearance rate has been less than 20ml/min. 9. Patients whose body weight 150kg was actually measured before entering the group. 10. Patients with granulocytopenia (defined as the absolute value of peripheral blood granulocytes < 1000 / µ L), or previous human immunodeficiency virus infection, or other severe immune deficiencies, such as leukemia, multiple myeloma, or patients with severe immunosuppression due to radiotherapy and chemotherapy or immunosuppressants after organ transplantation, or severe immunosuppression after the use of high-dose corticosteroids. 11. suspected or confirmed brain death patients; dying patients with survival expectations of less than 72 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Control rate of intracranial infection; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS 3m follow-up;mortality rate; | — |
Countries
China
Contacts
Public ContactXin Qu
Xuanwu Hospital, Capital Medical University
Outcome results
None listed