Azithromycin for infants at risk of poor growth and development: A pooled secondary analysis of two randomized

Mamadou Bountogo1, Mamadou Ouattara1, Clarisse Dah1

  • 1Centre de Recherche en Santé de Nouna, Burkina Faso.

Plos One
|August 8, 2025
PubMed

Insights

A single dose of azithromycin did not reduce mortality or wasting in infants at risk of poor growth. This study evaluated azithromycin

Area of Science:

  • Pediatrics
  • Infectious Diseases
  • Global Health

Background:

  • The World Health Organization (WHO) revised severe acute malnutrition (SAM) guidelines in 2023, emphasizing infants at risk of poor growth.
  • Routine antibiotic use for these infants is a priority research area for improving infant outcomes.

Purpose of the Study:

  • To assess the impact of azithromycin on infant mortality and wasting.
  • To evaluate azithromycin's effectiveness in preventing poor growth outcomes in high-risk infants.

Main Methods:

  • Pooled data from two randomized controlled trials in Burkina Faso involving 54,709 infants aged 1-12 weeks.
  • Infants identified as at-risk based on WHO criteria (low weight-for-age, weight-for-length, or MUAC) received a single oral dose of azithromycin or placebo.
  • Outcomes including mortality, underweight, wasting, and stunting were assessed at 6 months of age.

Main Results:

  • A total of 9,728 infants met the criteria for being at risk of poor growth.
  • No significant difference in mortality (1.3% vs. 1.1%) or wasting (20.6% vs. 20.2%) was observed at 6 months between the azithromycin and placebo groups.
  • Statistical analysis showed no evidence of benefit from azithromycin in this subgroup.

Conclusions:

  • Single-dose azithromycin administered to infants aged 1-12 weeks at risk of poor growth does not reduce mortality.
  • Azithromycin did not demonstrate improved growth outcomes, such as reduced wasting, in this vulnerable infant population.
Abstract

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