Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Mortality Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 190,238
- 试验地点
- 6
- 主要终点
- All-cause Mortality Rate in Children Aged 1-60 Months
研究概览
简要总结
Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood mortality. We propose a single multi-site (multi-country), cluster-randomized trial comparing communities randomized to oral azithromycin with those randomized to placebo. We hypothesize that mass azithromycin treatments will reduce childhood mortality.
详细描述
We will assess childhood mortality over three years, comparing communities where children aged 1-60 months receive biannual oral azithromycin ("Azithromycin" arm) for two years, to communities where the children receive biannual oral placebo ("Control" arm) for two years. During the third year at the Niger site only, everyone will receive azithromycin.
This is a cluster-randomized trial; at each site, communities within a contiguous area of 300,000 to 600,000 individuals will be randomized to azithromycin or placebo using simple random sampling.
Niger contingency study: In the event that mass distributions of oral azithromycin are proven to reduce mortality in 1-60 month-old children, then we will treat all communities in Niger with mass azithromycin distributions to test whether the intervention continues to reduce childhood mortality after the initial 2 years of mass treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Communities
- •The community location in target district.
- •The community leader consents to participation in the trial
- •The community's estimated population is between 200-2,000 people.
- •The community is not in an urban area.
- •Individuals - All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census.
排除标准
- •Individuals
- •Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
研究组 & 干预措施
Biannual mass oral azithromycin
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years.
In Niger during year 3, all communities will be offered azithroymcin.
干预措施: Azithromycin (Drug)
Biannual mass oral placebo
Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years
In Niger during year 3, all communities will be offered azithroymcin.
干预措施: Placebo (Drug)
结局指标
主要结局
All-cause Mortality Rate in Children Aged 1-60 Months
时间窗: 36 months
This was a pre-specified contingency study in Niger only in which all communities were treated with mass azithromycin during the third year of the study following the primary 24-month endpoint.
次要结局
- Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)(24 Months)
- Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death(24 months)
- All-cause and Cause-specific Health Clinic Visits in 1-60 Month-old Children(24 months)
- Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)(24 Months)
- Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)(24 Months)