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Clinical Question
Does a twice yearly dose of azithromycin reduce all-cause mortality in children in sub-Saharan Africa?
Bottom line
This study supports the use of twice yearly azithromycin for preschool children in sub-Saharan Africa. The benefit was not uniform, though, and was greatest in the youngest children and in those in the country with the worst infant mortality rate (Niger). 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Foundation
Setting: Population-based
Synopsis
Mass distribution of the antibiotic azithromycin has been used as a way to treat trachoma and prevent blindness in under-resourced settings, especially in sub-Saharan Africa. Observational studies have found associations between prophylactic mass distribution of azithromycin and lower mortality in children. This trial randomized 1533 small communities (population: 200 - 2000) in Niger, Malawi, and Tanzania to biannual mass distribution of a single dose of azithromycin 20 mg/kg or matching placebo to children aged 1 month to 59 months. Children who weighed less than 3800 grams were excluded. Approximately half of the study group was girls, and 60% of the children were between 2 years and 5 years of age. A house-to-house census was performed every 6 months to assess mortality and also to deliver the study medication or placebo. The study continued for five 6-month "census periods," with 97,047 children randomized to receive azithromycin and 93,191 children randomized to receive placebo. At the end of the study, there were a total of 323,302 person-years of follow-up. All-cause mortality was reduced significantly in the entire population (14.6 vs 16.5 deaths per 1000 person-years of follow-up; number needed to treat [NNT] = 526), although when looking at individual countries, only Niger saw a significant reduction (22.5 vs 27.5 deaths per 1000 person-years; NNT = 200). Reductions were seen in the other countries, but they were not statistically significant. The benefit was greatest in infants 1 month to 5 months old in all 3 countries. Of note, Niger has a much higher baseline mortality rate than the other 2 countries. Also, the mortality reduction tended to increase across the census periods, especially in Malawi. Although multiple comparisons is a concern, at least a small mortality reduction was seen in most subgroups. The study was funded by the Gates Foundation.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
also learned about definition of biannual. does mean every six months and biennial is once every two years.
Good poem
this set up is disturbing and does not touch the core of the problem being high infant death : you can not solve the problem with twice one dose of ab
Promoting mass use of antibiotics in countries with poor resources instead of addressing the underlying socioeconomic issues, seriously? this is the best Medical solution, just give kids antibiotics prophalactically? What about the information regarding adverse effects of treatment or development of antibiotic resistant strains. This really seems like a bandaid solution.
Third world related different population.
Interesting
Really highlights the differences in this little world and how privileged we are. Obviously it would be better to fix the conditions that lead to the catastrophic rates of illness and death. But neither I nor anyone else has a decent solution to these problems. Amazing to see how under these conditions an "obviously terrible" idea can save so many lives.
The review did not comment on drop-out rates of the two groups. The intention to treat is laudable in these trachoma prone infants & children
I practice in Canada, not sub-Saharan Africa. There is close to no similarity between my patients and those in the study population.
Should we shift antibiotics out of the 1st World and be deliberate in their use, and not just second hand drugs, in the 3rd ?
What is being treated with the Azithromycin?