The reading WAidid suggests this week is a recent article published on NEJM, Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children, analyzing the possibility of limiting the duration of antimicrobial treatment in order to reduce the risk of antimicrobial resistance among children with acute otitis media.
Next to the common cold, acute otitis media (AOM) is the most frequently diagnosed illness in children in the United States, and the most commonly cited indication for antimicrobial treatment. Some authors have arisen concerns about the possibility of the encouragement of antimicrobial resistance. A potential strategy for reducing the risk of antimicrobial resistance is to limit the duration of antimicrobial treatment.
The authors undertook the current noninferiority trial, involving children 6 to 23 months of age, to determine whether limiting antimicrobial treatment to 5 days, rather than using the standard 10-day regimen, would afford equivalent outcomes, and whether doing so also for subsequent episodes would lead to a reduction in the overall use of antimicrobial treatment, with a resulting reduction in the development of antimicrobial resistance. So, from January 2012 through September 2015, at Children’s Hospital of Pittsburgh, they enrolled 520 children with a diagnosis of AOM and with a history of at least two doses of pneumococcal conjugate vaccine. Clinical failure was observed in a greater percentage of children treated with amoxicillin–clavulanate for 5 days, than of those treated for 10 days (77 of 229 children, 34% vs 39 of 238, 16%). The results in subgroups consistently favoured the group of children assigned to receive the 10-day treatment. Overall, in the two groups combined, clinical failure rates were greater among children with exposure to three or more children for 10 or more hours per week, than among those with less exposure (P = 0.02), and greater among children with bilateral AOM, than in those with unilateral AOM (P<0.001). The mean symptom scores over the period from day 6 to day 14 were 1.61 in the 5-day group and 1.34 in the 10-day group (P = 0.07); the mean scores at the day-12-to-14 assessment were 1.89 versus 1.20 (P = 0.001). The percentage of children, whose symptom scores decreased more than 50% (indicating less severe symptoms) from baseline to the end of treatment, was lower in the 5-day group than in the 10-day group (181 of 227 children, 80% vs 211 of 233, 91%, P = 0.003). Overall, the percentage of children who had one or more recurrences of AOM was greater among children with residual effusion, than among those without residual effusion (48% vs 29%, P<0.001). Among children with recurrent episodes, the rate of clinical failure was consistently higher in the 5-day group than in the 10-day group (28% vs. 19%), and the criterion for noninferiority of the 5-day treatment was not met. The rates of residual middle-ear effusion after treatment of recurrences were similar in the two groups. The mean numbers of days on which children received systemic antimicrobial treatment were 21±13 in the 10-day group and 15±12 in the 5-day group (P<0.001).
After antimicrobial treatment for the index episode, the level of colonization with penicillin-susceptible strains of Streptococcus pneumoniae decreased in both the 10-day group and the 5-day group. There were no significant between-group differences in the rates of use of other health care services, of missed work, or of special childcare arrangements because of children’s illness or in the levels of parental satisfaction. The authors reported that reduced-duration treatment with amoxicillin–clavulanate for 5 days was less effective than standard-duration treatment for 10 days, with a magnitude of difference that exceeded the pre-specified noninferiority margin. They concluded that the treatment of AOM with amoxicillin–clavulanate for 5 days afforded less-favorable short-term outcomes than treatment for 10 days; in addition neither the rate of adverse events nor the rate of emergence of antimicrobial resistance was lower with the shorter regimen.
AUTHORS: Alejandro Hoberman, Jack L. Paradise, Howard E. Rockette, Diana H. Kearney, Sonika Bhatnagar, Timothy R. Shope, Judith M. Martin, Marcia Kurs-Lasky, Susan J. Copelli, D. Kathleen Colborn, Stan L. Block, John J. Labella, Thomas G. Lynch, Norman L. Cohen, MaryAnn Haralam, Marcia A. Pope, Jennifer P. Nagg, Michael D. Green, and Nader Shaikh