Treating AOM: 5 Days or 10?
Not treating acute otitis media (AOM) in children aged <3 years with antibiotics produces worse outcomes than providing antibiotic treatment, but an unanswered question is whether shorter durations of treatment could be appropriate in these younger children as a way of reducing antibiotic use. In a clinical trial in children aged 6-23 months, Hoberman and colleagues aimed to determine whether a 5-day course of antibiotic treatment was not inferior to a 10-day treatment course.
Study children were enrolled at Children's Hospital of Pittsburgh from 2012 to 2015. All children had AOM with onset no more than 48 hours before enrollment and had symptoms above an objective threshold determined by the researchers (assessed by looking for effusion, bulging, and scores on pain assessment tools). Parents were asked to report seven different items, including crying, irritability, tugging at the ears, fever, and other measures of how the child was feeling. The children were assigned to receive amoxicillin-clavulanate (90 mg/kg/day of the amoxicillin component) either for a standard duration of 10 days or for a reduced duration of 5 days followed by identical-looking placebo for 5 days.
The investigators contacted the families several times in the first week to ensure medication adherence and obtain symptom reports, and the children completed a clinical examination again at the end of therapy, usually at day 12-14. Parents recorded daily symptom scores in a diary. Finally, longer-term outcomes were assessed with in-office assessments every 6 weeks until each respective respiratory season ended.
The main outcome of each episode of AOM was clinical success or clinical failure. Clinical failure was an episode in which the child had worsening symptoms, worsening otoscopic exam findings, or failed to have complete or nearly complete eradication of symptoms by the end of the treatment course. The investigators considered recurrence of AOM to be any one episode that occurred after day 16 from the initial diagnosis. The primary analysis was based on a noninferiority approach.
Slightly more than half (51%) of the enrolled children were less than 1 year old, and 58% had exposure to three or more other children for at least 10 hours weekly. Approximately 55% of all of the children had what was considered a severe illness based on fever and pain, and 49% of the children had bilateral otitis at enrollment. At the time the trial was stopped, 520 children had been enrolled and randomly assigned. The study was discontinued early because an interim analysis showed that the shorter course was not performing in a noninferior manner, with too many failures among the children treated for only 5 days. Clinical failure was 34% in the 5-day treatment group compared with 16% in the10-day treatment group, correlating to a number-needed-to-treat of six to prevent one clinical failure.
Even subgroup analysis showed that 10 days of treatment performed consistently better than 5 days. Children who were exposed to three or more children for 10 or more hours weekly and children who had bilateral AOM were more likely to experience clinical failure. Symptom scores in the second week of enrollment (6-14 days) were consistently higher in the children who received 5 days of therapy compared with those who received 10 days of therapy. The odds of failure among those exposed to other children was 1.7, and it was 2.9 for children with bilateral otitis media.
Of interest, the differences in frequency of diarrhea, diaper dermatitis, and effusion at the 2-week assessment between the two groups was not statistically significant.
Well, you win some, and you lose some! We're very fortunate that investigators are continuing to evaluate these very practical and important treatment options for children with infections. The medical community has increasingly adopted the need for antimicrobial stewardship, and this was a notable effort to try to identify another population for whom we could reduce antibiotic exposure. Antimicrobial stewardship is a real need, but these data suggest that in these young children with AOM, the stewardship should not take the form of a reduced duration of therapy.
Although not shown directly by this study, a clinician can still contribute to antimicrobial stewardship in the setting of AOM by being more careful in making the otitis media diagnosis, and some online appendices for this article show some very interesting photos of the type of tympanic membrane findings that qualified as positive for the study. This study also reminds us that many children (almost two thirds, regardless of treatment group) will still have effusions 2 weeks after initiating antimicrobial treatment. In addition, it's also clinically important that a short course of therapy does not appear to be protective for the gastrointestinal disturbances that many children experience on amoxicillin-clavulanate.
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Cite this: Antibiotic Therapy for Acute Otitis Media in Children Under 2: Must We Go Long? - Medscape - Mar 07, 2017.