In Reply Dr Fleming-Dutra and colleagues express concerns about our study demonstrating the efficacy of early azithromycin use in the prevention of severe LRTI among children with prior severe LRTIs. We disagree with their conclusions.
Our study was conducted to identify a treatment approach that could modify illness severity for a common clinical problem, severe LRTIs with wheezing, which has significant associated morbidity and lacks highly effective therapy. The burden of disease experienced by these children and their families was significant, with a mean of 4.5 severe LRTI episodes and nearly 2.5 urgent visits per patient per year. Most needed systemic corticosteroids at least once in the prior year. Although the symptom complex that triggered initiation of azithromycin or placebo often included upper respiratory tract symptoms, the goal of therapy was to prevent progression to severe LRTIs, defined as the attendant need for oral corticosteroids, not simply reducing “additional rescue albuterol” use, as described by Fleming-Dutra and colleagues. Oral corticosteroid use carries significant risks,1 although recent studies suggest minimal to no benefit in this age group.2,3 Therefore, failure to detect differences in the secondary measures (urgent care visits, pneumonia, emergency visits, or hospitalizations), which the study was not adequately powered to address, does not diminish the potential clinical importance of our findings.
Bacharier LB, Guilbert TW, Martinez FD. Early Azithromycin Treatment to Prevent Severe Lower Respiratory Tract Illnesses in Children—Reply. JAMA. 2016;315(19):2122-2123. doi:10.1001/jama.2016.0921