Cluster-randomized Trial to Evaluate the Impact of Ciprofloxacin for Contacts of Cases of Meningococcal Meningitis as an Epidemic Response
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Epicentre
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Meningitis Attack Rate
研究概览
简要总结
This study evaluates the effect of antibiotic prophylaxis with ciprofloxacin, given to the contacts of meningitis cases, on the overall attack rate of meningitis during an epidemic. One third of enrolled villages will receive standard care; in one-third of villages, household contacts of meningitis cases will be offered a single dose of oral ciprofloxacin; and in one-third of villages, the entire village will be offered a single dose of oral ciprofloxacin after the notification of the first case in the village.
详细描述
Antibiotic prophylaxis is not currently recommended for contacts of cases during a meningitis epidemic in the African Meningitis Belt. Reactive vaccination campaigns are the preferred strategy for prevention during an epidemic.
A novel strain of meningococcus, Neisseria meningitidis serogroup C (NmC), began circulating in Nigeria in 2013 and caused a major epidemic with over 10 000 cases in Nigeria and Niger in 2015.
There is currently a global shortage of vaccine against NmC, and a recent WHO expert panel called for the formal evaluation of antibiotic prophylaxis as another epidemic response strategy.
When taken as a single dose, oral ciprofloxacin effectively eliminates nasopharyngeal carriage of meningococcus.
This trial aims to investigate two different antibiotic prophylaxis strategies during an epidemic of meningococcal meningitis: ciprofloxacin prophylaxis to household members of cases and village-wide prophylaxis after the notification of a case in a village. These two strategies will be compared to villages receiving standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resident in a village included in the study area
排除标准
- •Patients currently exhibiting symptoms of meningitis (to be immediately referred for further care)
- •Persons with a known allergy to fluoroquinolone antibiotics.
研究组 & 干预措施
Household prophylaxis
Chemoprophylaxis with a single dose of oral ciprofloxacin for household members of reported cases of meningitis. For participants age >12 years: 500 mg tablet; age 5-12 years: 250 mg tablet; age 1-4 years: 125 mg tablet; age 3-11 months: 100 mg (2 ml oral suspension); age <3 months: 75 mg (1.5 ml oral suspension).
干预措施: Ciprofloxacin (Drug)
Village prophylaxis
Chemoprophylaxis with ciprofloxacin in the setting of a village-wide distribution after the notification of the first case of meningitis in a village. For participants age >12 years: 500 mg tablet; age 5-12 years: 250 mg tablet; age 1-4 years: 125 mg tablet; age 3-11 months: 100 mg (2 ml oral suspension); age <3 months: 75 mg (1.5 ml oral suspension).
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Meningitis Attack Rate
时间窗: From enrollment of a village through study completion, an average of 3 months
The primary outcome aims to evaluate the impact of a chemoprevention strategy as a public health intervention during a meningitis outbreak, which is best evaluated by looking at the overall attack rates in the study area.
次要结局
- Proportion of participants with ciprofloxacin-resistant enterobacteriaceae in their stools(Prior to ciprofloxacin dosing (day 0) and at 7 days and 28 days post-ciprofloxacin dosing)
- Proportion of patients who received ciprofloxacin who develop meningitis(From enrollment of a village through study completion, an average of 3 months)