"While we believe there are differences in the frequency with which azithromycin causes hearing disorders, we think we have overestimated that frequency in both groups," Dr. Albert said.
At enrollment, 14% of the azithromycin and 15% of the placebo group were colonized with selected respiratory pathogens. Excluding those patients, 12% of the azithromycin group became colonized with respiratory flora during the study, compared with 28% of the placebo group at the 12-month assessment, a highly significant difference. Colonization with macrolide-resistant pathogens did not differ between the groups at baseline. However, during the study, 47 (81% of those who had culture obtained) in the azithromycin group had become colonized with resistant pathogens, compared with 108 (47% of those cultured) in the placebo group. No association was found between colonization and pneumonia, he said.
The study was funded by the National Heart, Lung, and Blood Institute. Dr. Albert stated that he had no relevant disclosures.