Post-craniotomy Bacterial Meningitis
Conditions
Interventions
Intervention Group:High-dose sulbactam sodium (administered as a 2g, every 8 hours) combined with vancomycin (given as a 1g infusion, every 12 hours ) plus meropenem (managed with a 2g infusion, every
Control Group:Vancomycin (given as a 1g infusion, every 12 hours ) plus meropenem (managed with a 2g infusion, every 8 hours)
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Patients who are aged from 18 to 65 years. 2) Patients who have underwent a major craniectomy (emergent or elective) , and have developed bacterial meningitis during the first 30 post-operative days. Bacterial meningitis will be diagnosed when it meet all of the following criteria: ? at least one of the following signs or symptoms is found positive: fever, headache, stiff neck, meningeal signs, cranial nerve signs, or changes in consciousness or metal status; ? at least one of the following is detected in CSF routine tests: increased WBC count (defined as "more than 1000/µL, of which over 75% are neutrophils" in this trial, elevated protein levels, or/and decreased glucose levels. 3) Written informed consent have been obtained from the above eligible patients or their legal representatives.
Exclusion criteria
Exclusion criteria: 1) Patients who have been diagnosed with central nervous system infections (bacterial, viral, fungal or protozoal, etc) before the craniectomy. 2) Positive gram stain or culture results detected in the CSF samples used for the diagnosis of bacterial meningitis when recruiting participants, which may guide the subsequent targeted antibiotic therapies. 3) Other organisms seen, by means of microscopy, in the CSF samples used for the diagnosis of bacterial meningitis when recruiting participants (e.g., cryptococcus or M.tuberculosis, etc.). 4) Patients with highly suspected polymicrobial infections of central nervous system. 5) Patients who have been known allergy to sulbactam, or any carbapenems or glycopeptides. 6) Patients previously receiving treatment with sulbactam or any antibiotic compounds containing sulbactam, or any carbapenems or glycopeptides (either topically or intravenously administrated) for more than 4 days prior to enrollment. 7) Patients who have previous carbapenem-induced seizures, or those who have been diagnosed with epilepsy requiring antiepileptic treatment. 8) Female patients who are pregnant or breastfeeding, or intend to breastfeed in the next 6 months. 9) Patients currently enrolled in or have participated in any other interventional trials within the past 6 months prior to enrollment. 10) Patients who have severe renal failure, with an estimated endogenous creatinine clearance below 20 ml/min prior to enrollment. 11) Patients' measured weight 150kg prior to enrollment. 12) Patients suffering from granulocytopenia (defined as absolute blood granulocyte count = cells per µL), or having known human immunodeficiency virus infection or any other severe immunodeficiency disorders (e.g., leukemiamultiple, myeloma, or the severe immunosuppression after the usage of immunosuppressive drugs following organ transplants, or chemo-therapy, radiation treatment or high-dose administration of glucocorticoids.) 13) Confirmed or suspected brain dead patients. 14) Moribund patients whose life expectancy < 72 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success or not for post-craniotomy bacterial meningitis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glasgow Outcome Scale; | — |
Countries
China
Contacts
Public ContactShi Guangzhi
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed