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In comparing high-dose azithromycin with high-dose amoxicillin-clavulanate for children with recurrent or persistent acute otitis media (AOM), Arrieta and colleagues reported that, at days 12 to 16, clinical success rates for the two regimens were comparable and that, at days 28 to 32, clinical success rates for azithromycin were superior (1). The study incorporated many favorable features, including a double-dummy design, stringent criteria for the diagnosis of AOM, and baseline tympanocentesis with culture of middle-ear contents. Unfortunately, the number of children whose baseline cultures were positive for pathogens was insufficient for the results of the study to be considered conclusive. Of 296 children studied, baseline middle-ear cultures were positive in only 163 (55%). Among children whose baseline pathogen was Streptococcus pneumoniae, clinical success rates at days 12 to 16 were 85% (22 of 26) in those receiving azithromycin versus 80% (31 of 39) in those receiving amoxicillinclavulanate (95% confidence interval [CI] of the difference in proportions, 13.7 to 23.9%). Corresponding values at days 28 to 32 were 65% (17 of 26) versus 67% (26 of 39) (95% CI of the difference, 24.8 to 22.2%). Among children whose baseline pathogen was Haemophilus influenzae, success rates at days 12 to 16 were 67% (24 of 36) for azithromycin versus 81% (25 of 31) for amoxicillin-clavulanate (95% CI of the difference, 34.7 to 6.8%). Corresponding values at days 28 to 32 were 47% (17 of 36) versus 52% (26 of 39) (95% CI of the difference, 28.4 to 19.6%). Given these CIs, the findings permit no inference either that the two regimens were equivalent or that either of the two regimens was superior to the other. However, the 95% CI of the difference in proportions at days 12 to 16 suggests that the efficacy of azithromycin for AOM caused by H. influenzae was less than that of amoxicillin-clavulanate, a circumstance that, as Arrieta et al. noted, has been reported previously (2). It was only with inclusion of the initially culturenegative children that the difference overall in clinical success rates between the two regimens at days 28 to 32 became statistically significant: 72% (107 of 148) for azithromycin versus 61% (88 to 144) for amoxicillin-clavulanate (P 0.047). Yet the superiority of any antimicrobial drug over another in treating culture-negative children would seem difficult to account for except on the basis of chance. For the subgroup of initially culture-positive children 2 years of age—the most therapeutically problematic subgroup—outcome data were not provided. The authors speculated that their relatively low culture positivity rate may have been attributable to suppression of bacterial growth by prior therapy or site-to-site variability in processing specimens. An alternative explanation would have been the possibility that some children had otitis media with effusion rather than AOM: a result would have been blurring of any differences in efficacy between the two regimens. In our limited experience, culture positivity rates in children with bona fide AOM have been as high in those already receiving antimicrobials as in those who have not been treated. In summary, the study by Arrieta et al., while incorporating many favorable features, cannot, in our judgment, be viewed as having answered the question it set out to address. REFERENCES

Study Design Questions in Treatment of Children with Acute Otitis Media