A single dose of azithromycin did not reduce the risk of death in healthy infants
A randomized clinical trial has shown that a single dose of the antibiotic azithromycin in healthy children in the first six months of life does not reduce the risk of death. More than 32,000 children participated in the study, which took place in Burkina Faso. The article was published in The New England Journal of Medicine.
In one study, scientists showed that mass distribution of the macrolide azithromycin reduced child mortality from all causes in regions with high mortality rates. On average, mortality rates were reduced by 14 to 25 percent in communities where children received azithromycin four times a year as part of routine checkups with their pediatrician.
The World Health Organization has since issued guidelines recommending twice-yearly mass prescribing of azithromycin to infants aged 1 to 11 months in regions with more than 60 infant deaths per 1,000 live births or more than 80 deaths among children under age 5 per 1,000 live births. However, it is not known whether a positive effect would be seen with less frequent administration of the antibiotic, nor is it known to what extent the side effects of the drug might offset the benefit of the antibiotic.
Therefore, scientists led by Catherine Oldenburg of the University of California, San Francisco, conducted a clinical trial involving 32,877 infants who were divided equally into an azithromycin group and a placebo group. The mean age of the infants in the azithromycin group was 6.6 weeks and the mean age of the infants in the placebo group was 6.7 weeks. A total of 15734 infants in the azithromycin group and 15701 in the placebo group reached analysis at six months. Children in the azithromycin group received the drug at a single dose of 20 milligrams per kilogram of body weight between 5 and 12 weeks of age at a pediatrician's visit.
A total of 82 children in the azithromycin group and 75 children in the placebo group died before six months of age. This corresponded to a risk ratio of 1.09 with statistical significance of p = 0.58. In no subgroup were the researchers able to find a significant beneficial effect of this azithromycin regimen on pediatric mortality.
Six serious adverse events were reported during the study, including five hospitalizations in the azithromycin group within 14 days of taking the drug, but these were not considered as possibly related to trial participation.
This study shows that lower doses of azithromycin do not help reduce child mortality in developing countries in the same way as in the previous study. These findings will help optimize the prevention approach and logistics of supplying the antibiotic to Africa and other regions.