Pneumococcal meningitis is an infection of the membrane that covers the brain. It is a serious infection which is currently treated with a combination of corticosteroids (dexamethasone) and 3rd generation cephalosporins. Nevertheless, complications associated with meningitis are relatively frequent and severe. Recent animal studies have shown that another antibiotic, daptomycin, can reduce the mortality and long-term effects of pneumococcal meningitis. Daptomycin is widely used worldwide in humans for other diseases, with few side effects. This study aims to evaluate the effect of daptomycin on the proliferation of the bacterial infection, and therefore on inflammation. Daptomycin will be added to the currently recommended treatment with the same dosage used for other diseases. Roughly 130 patients with suspected pneumococcal meningitis admitted to the emergency departments of hospitals throughout France will be asked to participate in this study. The participation period will last approximately 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Daptomycin will be given by intravenous infusion and administered over a 30 minutes infusion, daily, for 8 days and at the dosis of 10mg/kg/day.
CHU Dijon Bourgogne
Dijon, France
Disability-free survival, assessed with the modified Rankin Scale (mRS)
Time frame: At Day 30
Overall mortality
Time frame: At Day 30 and Day 90
Disability level assessed with the mRS in surviving patients
Time frame: At Day 30 and Day 90
Disability level assessed with the Glascow Coma Scale and the Glasgow Outcome Scale in the overall efficacy population
Time frame: At Day 30 and Day 90
Disability level assessed with mini-mental score in surviving patients
Time frame: At Day 30 and Day 90
Hearing loss assessed with the Hearing Handicap Inventory test
Time frame: At Day 30 and Day 90
Hearing loss assessed with audiometry
Time frame: At Day 30
Hearing loss assessed with the Hearing-it test
Time frame: At Day 30
Quality of life assessed with the 12-Item Short Form Health Survey (SF-12)
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Time frame: At Day 30 and Day 90
Quality of life assessed with WHO QOL BREF
Time frame: At Day 30 and Day 90
Number of days without hospitalisation (including ICU)
Time frame: At Day 30 and Day 90
Number of days without antimicrobial therapy
Time frame: At Day 30
Frequency and type of side effects related to daptomycine
Time frame: Within 30 days after daptomycin start
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