Safety of azithromycin in infants under six months of age in Niger: A community randomized trial

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Catherine E Oldenburg1,2,3, Ahmed M Arzika4, Ramatou Maliki4

  • 1Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.

Plos Neglected Tropical Diseases
|November 13, 2018
PubMed

Insights

Mass azithromycin distribution in infants aged 1-5 months showed comparable safety to placebo. This finding supports considering younger infants for azithromycin-based child mortality and trachoma control programs.

Area of Science:

  • Global Health
  • Pediatrics
  • Infectious Disease Epidemiology

Background:

  • Mass azithromycin distribution is a strategy to reduce child mortality in under-5 populations.
  • Current trachoma control programs typically administer azithromycin to infants aged 6 months and older.
  • This study investigated the safety of administering azithromycin to younger infants (1-5 months).

Purpose of the Study:

  • To assess the safety and adverse events associated with mass azithromycin distribution in infants aged 1-5 months.
  • To compare the incidence of adverse events between azithromycin-treated and placebo-treated infants in this age group.
  • To inform potential inclusion of younger infants in large-scale azithromycin distribution programs.

Main Methods:

  • A community-randomized trial was conducted in Niger, comparing biannual mass azithromycin distribution to placebo.
  • Active surveillance of adverse events was performed in infants aged 1-5 months at the time of treatment.
  • Caregivers of 1,712 infants were surveyed for reported adverse events, including diarrhea, vomiting, and skin rash.

Main Results:

  • Approximately one-third of infants experienced at least one adverse event, with similar rates in the azithromycin (29.6%) and placebo (34.3%) groups (RR 0.86, P=0.23).
  • Diarrhea was less common in the azithromycin group (19.3%) compared to placebo (28.1%, RR 0.68, P=0.03).
  • No cases of infantile hypertrophic pyloric stenosis were reported.

Conclusions:

  • Mass azithromycin distribution to infants aged 1-5 months appears to be safe.
  • The findings suggest that younger infants could potentially be included in broader azithromycin-based child mortality or trachoma control initiatives.
  • Further evaluation of efficacy alongside safety is warranted for program expansion.
Abstract

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