Treatment of AOM: 5 days or 10?
Treatment of acute otitis media (AOM) in children under 3 years of age with antibiotics to reduce the use of antibiotics, but an unanswered question is whether the shorter duration of treatment might be appropriate in these children as a way to reduce the use of antibiotics. 1) In a clinical trial in children aged 6-23 months, Hoberman et al. sought to determine whether a 5-day antibiotic treatment was not less than a 10-day treatment.
The children in the study were enrolled at Children’s Hospital in Pittsburgh from 2012 to 2015. All children had AOMs started no later than 48 hours prior to enrollment and had symptoms above a target threshold determined by the investigators (assessed by the Search for spill, pain assessment tools). Parents were asked to report seven different items, including crying, irritability, pulling in the ears, fever, and other measures of how the child felt. Children were assigned to receive amoxicillin-clavulanate (90 mg / kg / day amoxicillin component) either for a standard duration of 10 days or for a reduced duration of 5 days followed by an identical-looking placebo for 5 days.
Researchers contacted families several times during the first week to ensure adherence to the medication and to 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 results were evaluated with in-office evaluations every 6 weeks until each respective respiratory season ended.
The main outcome of each AOM episode was clinical success or clinical failure. Clinical failure was an episode in which the child had symptoms that worsened, worsened the results of the otoscopic examination, or did not achieve complete or near complete eradication of symptoms at the end of treatment. The researchers considered the recurrence of AOM as any episode that occurred after day 16 from the initial diagnosis. The primary analysis was based on a non-inferiority approach.
Results of the study
A little more than half (51%) of enrolled children were less than 1 year old, and 58% had exposure to three or more other children at least 10 hours per week. Approximately 55% of all children had what was considered a serious illness based on fever and pain, and 49% of children had bilateral otitis on enrollment. At the time the trial was stopped, 520 children had been enrolled and randomized. The study was interrupted early because an interim analysis showed that the shorter course was not performing in a non-inferior fashion, with too many failures among children treated for only 5 days. Clinical failure was 34% in the 5-day treatment group, compared to 16% in the 10-day treatment group, correlating with a required number of treating 6 to prevent clinical failure.
Even subgroup analysis showed that 10 days of treatment were consistently performed better than 5 days. Children who were exposed to three or more children for 10 or more hours per week 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 children who received 5 days of therapy compared to those who received 10 days of therapy. The odds of failure among those exposed to other children were 1.7, and was 2.9 for children with bilateral otitis media.
Of interest, differences in the frequency of diarrhea, diaper rash and effusion at the 2-week assessment between the two groups were not statistically significant.
Point of view
Well, you win something and you lose something. We are very fortunate that researchers continue to evaluate these very practical and important treatment options for children with infections. The medical community has increasingly adopted the need for antimicrobial administration, and this was a remarkable effort to try to identify another population for which we could reduce exposure to antibiotics. Antimicrobial administration is a real necessity, but these data suggest that in these young children with AOM, stewardship should not take the form of a reduced duration of therapy.
Although not shown directly in this study, a clinician may still contribute to antimicrobial administration in the establishment of AOM by being more careful in making otitis media diagnosis, and some online appendices for this article show some very interesting pictures Of the type of tympanic membrane. Results that qualified as positive for the study. This study also reminds us that many children (almost two-thirds, regardless of the treatment group) will still have effusions 2 weeks after initiating antimicrobial treatment. In addition, it is also clinically important that a short therapy course does not appear to be protective for the gastrointestinal disorders that many children experience with amoxicillin-clavulanate.