阿奇霉素促进尼日尔儿童生存：死亡率和耐药性试验 (AVENIR)

有源比较器：阿奇罗 1-11

1-11 个月大的儿童每年两次根据体重或身高口服阿奇霉素混悬液，12-59 个月大的儿童口服安慰剂或不干预

药品：阿奇霉素

阿奇霉素将以儿童口服混悬液形式作为直接观察剂量给药：

1. 儿童单剂量 20mg/kg（成人最大剂量可达 1g）
2. 对于 1-11 个月大的儿童，将使用基于体重或年龄的剂量
3. 对于 12-59 个月大的儿童，将通过尼日尔沙眼项目目前执行的身高棒近似法使用基于身高的剂量

其他名称：

• 希舒美

其他：安慰剂

安慰剂将作为儿童口服混悬液形式的直接观察剂量给药：

1. 儿童单剂量 20mg/kg（成人最大剂量可达 1g）
2. 对于 1-11 个月大的儿童，将使用基于体重的剂量
3. 对于 12-59 个月大的儿童，将通过尼日尔沙眼项目目前执行的身高棒近似法使用基于身高的剂量

有源比较器：阿奇罗 1-59

1-59 个月大的儿童每年两次口服阿奇霉素混悬液，剂量基于年龄、体重或身高

药品：阿奇霉素

阿奇霉素将以儿童口服混悬液形式作为直接观察剂量给药：

1. 儿童单剂量 20mg/kg（成人最大剂量可达 1g）
2. 对于 1-11 个月大的儿童，将使用基于体重或年龄的剂量
3. 对于 12-59 个月大的儿童，将通过尼日尔沙眼项目目前执行的身高棒近似法使用基于身高的剂量

其他名称：

• 希舒美

安慰剂比较：安慰剂

1-59 个月大的儿童每年两次根据体重或身高口服安慰剂

其他：安慰剂

安慰剂将作为儿童口服混悬液形式的直接观察剂量给药：

1. 儿童单剂量 20mg/kg（成人最大剂量可达 1g）
2. 对于 1-11 个月大的儿童，将使用基于体重的剂量
3. 对于 12-59 个月大的儿童，将通过尼日尔沙眼项目目前执行的身高棒近似法使用基于身高的剂量

全因死亡率（1-59个月大）

1-59个月大的儿童死亡率（每1000人年的死亡人数），比较Azithro 1-59和安慰剂武器。

全因死亡率（1-11个月大）

1-11个月大的儿童的死亡率（每1000人年的死亡人数死亡人数），比较Azithro 1-11和安慰剂武器。

全因死亡率（12-59个月大）

12-59个月大的儿童死亡率（每1000人年的死亡人数）与Azithro 1-11和Azithro 1-59社区之间的率相比。

Prevalence of Resistance to Macrolides - Nasopharyngeal Swabs (1-59 Months Old)

Prevalence of macrolide resistance among pneumococcus-positive nasopharyngeal swabs collected from children aged 1-59 months after 4 distributions. Resistance was assessed among culture-positive pneumococcal isolates from nasopharyngeal swabs.

Load of Genetic Determinants of Resistance to Macrolides - Rectal Swabs (1-59 Months Old)

Community-level load of macrolide antimicrobial resistance determinants in pooled rectal swabs collected from children aged 1-59 months after four biannual distributions. Rectal swabs from each community were pooled and analyzed using metagenomic DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts.

Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months

All-cause mortality incidence rate among children aged 1-11 months who had weight measured during at least one census round and had a valid weight-for-age z-score calculated using the World Health Organization Child Growth Standards. Nutritional status was assessed at the beginning of each census interval. This measure reports the overall mortality rate for this analysis population by randomized treatment arm and is not stratified by weight-for-age z-score subgroup. Mortality rates are reported as deaths per 1,000 person-years.

Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Guardians

Community-level loads of macrolide antimicrobial resistance determinants in nasopharyngeal swabs collected from guardians of children eligible for treatment after four biannual distributions. Nasopharyngeal swabs from each community were pooled and analyzed using DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts; log-transformed values were used only for inferential statistical analyses.

Program Costs Per Dose Delivered

Program cost per dose delivered was estimated using routine administrative data and micro-costing activities. Costs were calculated per dose delivered and were not stratified by randomized treatment arm.

Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Children Aged 7-12 Years

Community-level loads of macrolide antimicrobial resistance determinants in nasopharyngeal swabs collected from children aged 7-12 years after four biannual distributions. Nasopharyngeal swabs from each community were pooled and analyzed using DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts; log-transformed values were used only for inferential statistical analyses.