To the Editor.

Ruohola et al demonstrate that placebo-controlled trials can be performed in young children, and time-to-resolution endpoints can be measured in such trials. Recent US Food and Drug Administration meetings2,3,4  have discussed the need for placebo-controlled antimicrobial trials in potentially self-resolving bacterial infections and the endpoints for such trials.

Unfortunately, the clinical relevance of the time to resolution of tube otorrhea is unclear. The authors state that acute otitis media (AOM) is associated with tube otorrhea when accompanied by acute symptoms. The authors show that the majority of children had “respiratory symptoms,” but these may not be the same as symptoms of AOM. If acute symptoms differentiate AOM from tube otorrhea alone, then the resolution of acute symptoms should be the primary endpoint. Measuring the time to resolution of acute symptoms rather than measuring outcomes at some fixed time point is...

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