Azithromycine Pour la Vie Des Enfants au Niger - Implémentation et Recherche: Essai mortalité et résistance (Azithromycin for Child Survival in Niger: Programmatic Trial)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 169,707
- 试验地点
- 1
- 主要终点
- Prevalence of Genetic Determinants of Macrolide Resistance From Population-based Samples
研究概览
简要总结
The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings. The proposed trial aims to demonstrate and evaluate large-scale implementation of azithromycin to children aged 1-11 months old in the context of a programmatic setting while monitoring mortality and resistance antimicrobial resistance.
详细描述
In the Programmatic Trial, community health centers (also known as "CSIs" or "Centres de Santé Intégrés") will be randomized to one of two arms: 1) programmatic azithro 1-11: biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers or 2) no intervention: no distribution of azithromycin. A total of 2,490 communities within selected CSIs will be included .
All communities in both arms receive routine health services offered by community health workers working for the Niger Ministry of Health's community health program.
Mortality will be monitored through birth histories. Mortality and morbidity will also be monitored using routinely collected community and clinic visit data. Antimicrobial resistance will be monitored in a subset of eligible CSIs.
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
- None
盲法说明
Participants, investigators, and program implementers will not be actively masked from the study arm allocation given that no placebo will be used. Outcome assessors and data analysts will be masked.
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
- •Distinguishable from neighboring communities
- •Verbal consent of community leader(s)
- •Exclusion criteria:
- •Inaccessible or unsafe for study team
- •"Quartier" designation on national census
- •At the individual-level, eligibility includes:
- •Inclusion criteria:
- •Age 1-11 months
- •Primary residence in a study community
- •Verbal consent of caregiver/guardian for study participation
- •Exclusion criteria:
- •Known allergy to macrolides
- •Population-based sample collections
- •At the community-level, eligibility includes:
- •Inclusion criteria:
- •Location in study region
- •Distinguishable from neighboring communities
- •Verbal consent of community leader(s)
- •Exclusion criteria:
- •Inaccessible or unsafe for study team
- •Included in MORDOR trials
- •Not randomly selected
- •At the individual-level, eligibility includes:
- •Inclusion criteria:
- •Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment
- •Primary residence in a study community selected for sample collections
- •Verbal consent of caregiver/guardian for study participation
- •Exclusion criteria:
- •Not on list of randomly selected participants from the census
排除标准
- 未提供
研究组 & 干预措施
Programmatic azithro 1-11
Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers
干预措施: Azithromycin for Oral Suspension (Drug)
结局指标
主要结局
Prevalence of Genetic Determinants of Macrolide Resistance From Population-based Samples
时间窗: 2 years
Prevalence of genetic determinants of macrolide resistance including those determinants known to be found in Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus in nasopharyngeal swabs in children aged 1-59 months from population-based samples after 1 year of distribution
Load of Genetic Determinants of Macrolide Resistance From Population-based Samples
时间窗: 2 years
Load of genetic determinants of resistance to macrolides including those determinants known to be found in Campylobacter spp, Salmonella spp, Shigella spp, and Escherichia coli from rectal swabs in children 1-59 months old from population-based samples, defined as read number per million base pairs, using DNA-seq (metagenomic deep sequencing).
次要结局
- Prevalence of Genetic Determinants of Macrolide Resistance From Clinic-based Samples(2 years)
- Load of Genetic Determinants of Macrolide Resistance From Clinic-based Samples(2 years)
- Number of All-cause Clinic Visits(2 years)