Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Disability-free survival, assessed with the modified Rankin Scale (mRS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons aged over 18 years
- •With Suspected pneumococcal meningitis :
- •clinical presentation evocative of pneumococcal meningitis : acute onset of ,meningeal signs, history of cranial trauma or fistula, knowledge of alteration of humoral immunity,, asplenia, alcoholism with/or
- •clearly purulent CSF with/ or,
- •presence of diplococcus on the Gram stain of CSF or positive pneumococcal antigen in the CSF, or polymorphonuclear cells in CSF > 100
- •Written consent or inclusion in an emergency
- •Affiliation to a social security system
排除标准
- •Contraindication to cephalosporin
- •Immediate and severe hypersensitivity to β-lactam antimicrobial
- •Contraindication to dexamethasone
- •Contraindication to daptomycin
- •Previous exposition to daptomycin (within one year)
- •Women who are able to procreate without effective contraception and pregnant or breastfeeding women
- •Patients under ward of court
- •Refusal at any time after acceptation of the study from the patient or her/his legal representative.
研究组 & 干预措施
Patients
干预措施: Daptomycin (Drug)
结局指标
主要结局
Disability-free survival, assessed with the modified Rankin Scale (mRS)
时间窗: At Day 30
次要结局
- Disability level assessed with the Glascow Coma Scale and the Glasgow Outcome Scale in the overall efficacy population(At Day 30 and Day 90)
- Quality of life assessed with the 12-Item Short Form Health Survey (SF-12)(At Day 30 and Day 90)
- Overall mortality(At Day 30 and Day 90)
- Hearing loss assessed with the Hearing Handicap Inventory test(At Day 30 and Day 90)
- Hearing loss assessed with the Hearing-it test(At Day 30)
- Disability level assessed with the mRS in surviving patients(At Day 30 and Day 90)
- Disability level assessed with mini-mental score in surviving patients(At Day 30 and Day 90)
- Hearing loss assessed with audiometry(At Day 30)
- Quality of life assessed with WHO QOL BREF(At Day 30 and Day 90)
- Number of days without hospitalisation (including ICU)(At Day 30 and Day 90)
- Number of days without antimicrobial therapy(At Day 30)
- Frequency and type of side effects related to daptomycine(Within 30 days after daptomycin start)