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Spillover of Azithromycin Mass Drug Administration and Child Survival: A Secondary Analysis of a Cluster-Randomized
Ahmed M Arzika1, Abdou Amza2, Ramatou Maliki1
1Centre de Recherche et Interventions en Santé Publique, Birni N'Gaoure, Niger.
Insights
Mass azithromycin administration for child survival may reduce infant mortality, especially when older children in the household also receive treatment. This finding supports broader public health strategies for child health.
Area of Science:
- Global Health
- Infectious Diseases
- Pediatrics
Background:
- World Health Organization guidelines recommend mass azithromycin administration for infants (1-11 months) to improve child survival.
- Previous studies included a wider age range (1-59 months), and the AVENIR trial indicated potential benefits when older children (12-59 months) in the same household were included.
Purpose of the Study:
- To investigate the potential spillover effect of azithromycin mass drug administration.
- To examine the association between azithromycin treatment and mortality in infants (1-11 months) based on the presence of older children (12-59 months) in the household.
Main Methods:
- Secondary analysis of the AVENIR adaptive cluster-randomized clinical trial in Niger.
- Compared all-cause mortality in infants (1-11 months) across three arms: azithromycin for children (1-59 months), azithromycin for infants (1-11 months) with placebo for older children, and placebo for all children.
- Subgroup analysis based on the presence of a child aged 12-59 months in the household.
Main Results:
- Mortality rates per 1000 person-years were 18.5 in the child arm, 22.3 in the infant arm, and 23.9 in the placebo arm.
- Among infants with an older sibling, the incidence rate ratio for mortality comparing the child arm to the infant arm was 0.78 (95% CI, 0.65-0.93).
- No statistically significant interaction was found for the presence of an older sibling, but trends suggested lower mortality in infants living with treated older children.
Conclusions:
- While not statistically significant, the results suggest a potential mortality benefit for infants (1-11 months) when older children (12-59 months) in the same household receive mass azithromycin treatment.
- Findings support exploring broader age-targeted mass drug administration strategies for azithromycin in child survival programs.
Importance:
World Health Organization guidelines on azithromycin mass drug administration for child survival target infants aged 1 to 11 months, although prior studies included those aged 1 to 59 months. The AVENIR trial suggested that infants aged 1 to 11 months have lower mortality if children aged 12 to 59 months in the same household are also included.
Objective:
To assess the possibility of a spillover effect by examining the association of azithromycin and mortality among children aged 1 to 11 months in subgroups defined by the presence of a child aged 12 to 59 months in the same household.
Design, Setting, And Participants:
This exploratory secondary analysis of the AVENIR (Azithromycine Pour la Vie des Enfants au Niger: Implementation et Recherche) adaptive cluster-randomized clinical trial was performed in 3000 rural and periurban communities in Niger. AVENIR communities were randomized to 3 arms and followed up for 2 years (November 24, 2020, to July 31, 2023). Study arms consisted of children aged 1 to 59 months receiving azithromycin (child arm); infants aged 1 to 11 months receiving azithromycin with placebo to children aged 12 to 59 months (infant arm); and children aged 1 to 59 months receiving placebo (placebo arm). Participants, investigators, data collectors, and data analysts were masked to randomization.
Intervention:
A single 20-mg/kg dose of oral azithromycin or placebo administered by study staff biannually.
Main Outcomes And Measures:
All-cause mortality in infants aged 1 to 11 months (deaths per 1000 person-years) measured through biannual census. Subgroups were defined by the presence of a child aged 12 to 59 months in the household recorded during the census.
Results:
After exclusions, 2883 communities and 98 969 infants aged 1 to 11 months were included in the analysis. Among the 23 770 infants in allocation 1 at baseline, mean (SD) age was 6.2 (3.1) months and 11 974 (50.4%) were female. Mortality was 18.5 (95% CI, 16.7-20.4) deaths per 1000 person-years in the child arm, 22.3 (95% CI, 20.0-24.7) in the infant arm, and 23.9 (95% CI, 21.6-26.2) in the placebo arm. The incidence rate ratio comparing mortality in the child and infant arms among children with an older sibling was 0.78 (95% CI, 0.65-0.93) compared with 0.91 (95% CI, 0.73-1.15; P = .26 for interaction) among those without. Comparing the infant and placebo arms, the incidence rate ratio among children with an older sibling was 0.96 (95% CI, 0.81-1.14) compared with 0.90 (95% CI, 0.71-1.12; P = .61 for interaction) among those without.
Conclusions And Relevance:
In this secondary analysis of a cluster-randomized clinical trial, interaction for the presence of a older sibling was not statistically significant, but results were consistent with lower mortality among infants aged 1 to 11 months living with older, treated children.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04224987.
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