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Preventive oral azithromycin has reduced incidence of trachoma and, incidentally, other childhood infection in clinical trials in Africa. Hypothesizing that mass prophylaxis with azithromycin would reduce overall mortality in young African children, investigators conducted a randomized trial in children aged 1 to 59 months in Malawi, Niger, and Tanzania. This cluster-randomized trial compared community-based randomization to oral azithromycin (about 20 mg per kg of body weight, administered at four 6-month intervals) versus placebo. There were 1533 communities with populations of 200 to 2000 each. The trial was approved by ethics committees of each country and the home ethics committees of each investigator.
In each country, there was a mort…