Azithromycine Pour la Vie Des Enfants au Niger II
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3,300,000
- 试验地点
- 1
- 主要终点
- Load of genetic determinants of resistance to macrolides - rectal swabs
研究概览
简要总结
Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years.
详细描述
AVENIR II is a cluster-randomized adaptive platform trial designed to evaluate community health interventions in Niger. The initial focus is to monitor under-5 mortality and antimicrobial resistance as the azithromycin MDA for child survival program expands in Niger, with the following specific aims:
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Mortality.
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To conduct surveillance of mortality over time compared to the Sustainable Development Goal targets for under-5 mortality reduction. As this intervention is not intended to continue indefinitely, surveillance against a target is needed to determine when to stop.
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To continue to evaluate the effectiveness of azithromycin MDA to reduce under-5 mortality. Given the risk of AMR, the effectiveness of the intervention over time is needed to fully weigh the risks against the benefits.
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Antimicrobial Resistance. To determine the impact of azithromycin MDA on AMR in population- and clinic-based samples.
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
- Single (Outcomes Assessor)
盲法说明
Participants, community health workers delivering the intervention, and team members supervising the program will not be masked. One biostatistician and one data analyst will remain unmasked to prepare the randomization sequence. Masked personnel include outcome assessors as well as the biostatistician and data analyst conducting the data analyses.
入排标准
- 年龄范围
- 1 Month 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CSI-level for mortality and AMR monitoring:
- •Located in a region participating in the program
- •Designated as rural by local study team
- •Selected for participation in monitoring activities
- •Safe and accessible for study teams
- •Verbal approval from community leaders
- •Individual level for mortality monitoring:
- •Residing in the catchment area of an eligible CSI
- •Selected for participation in monitoring activities
- •Age between 12 and 55 years old
- •Verbal approval from participant
- •Individual-level for AMR monitoring:
- •Residing in the catchment area of an eligible CSI
- •Selected for participation in monitoring activities
- •Age between 1 and 59 months old
- •Verbal approval from a caregiver or guardian
排除标准
- •At the community-level:
- •Designated as urban by local study team
- •Inaccessible or unsafe for study team
- •At the individual-level:
- •Known allergy to macrolides
研究组 & 干预措施
Continuous Distribution
Azithromycin distribution to children 1-59 months of age for four years using a door-to-door delivery approach via existing community health workers
干预措施: Azithromycin for Oral Suspension (Drug)
Stop Distribution
Stopping azithromycin distribution after two years to children 1-59 months of age using a door-to-door delivery approach via existing community health workers
干预措施: Azithromycin for Oral Suspension (Drug)
Delayed Distribution
Delayed, by two years, azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers
干预措施: Azithromycin for Oral Suspension (Drug)
结局指标
主要结局
Load of genetic determinants of resistance to macrolides - rectal swabs
时间窗: 4 years
Load of genetic determinants of resistance to macrolides from rectal swabs in children 1-59 months old after 4 years of distributions, comparing the continue and stop arms
All-cause mortality
时间窗: 4 years
Under-5 mortality rate (U5MR, deaths per 1,000 live births) assessed by pregnancy history at 4 years, comparing the continue and stop arms
Prevalence of resistance to macrolides - nasopharyngeal swabs
时间窗: 4 years
Prevalence of macrolide-resistant pneumococcus from nasopharyngeal swabs in children 1-59 months old after 4 years of distributions, comparing the continue and stop arms
All-cause mortality
时间窗: 2 years
Under-5 mortality rate (U5MR, deaths per 1,000 live births) assessed by pregnancy history at 2 years from the first treatment distribution, comparing the intervention and delayed arms
Prevalence of resistance to macrolides - nasopharyngeal swabs
时间窗: 2 years
Prevalence of macrolide-resistant pneumococcus from nasopharyngeal swabs in children 1-59 months old after 2 years of distributions, comparing the intervention and delayed arms
Load of genetic determinants of resistance to macrolides - rectal swabs
时间窗: 2 years
Load of genetic determinants of resistance to macrolides from rectal swabs in children 1-59 months old after 2 years of distributions, comparing the intervention and delayed arms
次要结局
- Number of clinic visits - infectious(4 years)
- Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs(4 years)
- Program Cost Per Dose Delivered(2 years)
- Number of clinic visits - infectious(2 years)
- Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs(2 years)
- Prevalence of Reported Illness(2 years)