It has been suggested that azithromycin might prevent a number of infectious diseases, including malaria, infectious diarrhea, and pneumonia. A study was conducted to test that theory specifically in preschool-age children.

The cluster-randomized trial was conducted in communities in Malawi, Niger, and Tanzania. Children ages one month to 59 months were identified in five twice-yearly censuses and given a single directly observed dose of oral azithromycin (approximately 20 mg/kg of body weight) or placebo. The primary outcome was the community-level, aggregate, three-country mortality rate as determined from the twice-yearly censuses.

The trial involved 1,533 communities randomly selected to be in the intervention or control arm. At baseline census, 97,047 children were enrolled in the azithromycin group and 93,191 in the placebo group. Over the five census visits, 323,302 person-years were monitored. In the three countries combined, the annual mortality rates among enrolled subjects were 14.6 deaths per 1,000 person-years in communities in the azithromycin arm and 16.5 deaths per 1,000 person-years in communities in the placebo arm, for a difference of 13.5% between the azithromycin group and the placebo group. The effect of azithromycin was greatest in children one to five months of age, in whom the mortality rates were also highest in the three countries. Azithromycin efficacy didn't differ significantly by country, age group, treatment period, or treatment coverage.

The authors caution that the development of antibiotic resistance during mass distribution could reverse the mortality benefit, although that wasn't observed in this trial. Nonetheless, that possibility, as well as the cost and risk of adverse effects, must be considered.

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