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Shortening amoxicillin/clavulanate treatment of acute otitis media from 10 days to 5 days in children 6 months to 23 months of age was associated with an increased clinical failure rate and worsening symptoms. They didn’t find an increased rate of colonization with resistant organisms with the longer duration of antibiotics either.
Spoon Feed: For kids 6 – 23 months with acute otitis media, 10 days of antibiotic therapy is better than 5 days. But EM Nerd had some issues with this study. See why.
Abstract
N Engl J Med. 2016 Dec 22;375(25):2446-2456. doi: 10.1056/NEJMoa1606043.
Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children.
Hoberman A1, Paradise JL1, Rockette HE1, Kearney DH1, Bhatnagar S1, Shope TR1, Martin JM1, Kurs-Lasky M1, Copelli SJ1, Colborn DK1, Block SL1, Labella JJ1, Lynch TG1, Cohen NL1, Haralam M1, Pope MA1, Nagg JP1, Green MD1, Shaikh N1.
Author information:
1From the Department of Pediatrics, University of Pittsburgh School of Medicine, Children’s Hospital of Pittsburgh of the University of Pittsburgh Medical Center (UPMC) (A.H., J.L.P., D.H.K., S.B., T.R.S., J.M.M., M.K.-L., S.J.C., D.K.C., M.H., M.A.P., J.P.N., M.D.G., N.S.), the Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh (H.E.R.), and Children’s Community Pediatrics (J.J.L., T.G.L., N.L.C.) – all in Pittsburgh; and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Abstract
Background
Limiting the duration of antimicrobial treatment constitutes a potential strategy to reduce the risk of antimicrobial resistance among children with acute otitis media.
Methods
We assigned 520 children, 6 to 23 months of age, with acute otitis media to receive amoxicillin-clavulanate either for a standard duration of 10 days or for a reduced duration of 5 days followed by placebo for 5 days. We measured rates of clinical response (in a systematic fashion, on the basis of signs and symptomatic response), recurrence, and nasopharyngeal colonization, and we analyzed episode outcomes using a noninferiority approach. Symptom scores ranged from 0 to 14, with higher numbers indicating more severe symptoms.
Results
Children who were treated with amoxicillin-clavulanate for 5 days were more likely than those who were treated for 10 days to have clinical failure (77 of 229 children [34%] vs. 39 of 238 [16%]; difference, 17 percentage points [based on unrounded data]; 95% confidence interval, 9 to 25). 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). We found no significant between-group differences in rates of recurrence, adverse events, or nasopharyngeal colonization with penicillin-nonsusceptible pathogens. Clinical-failure rates were greater among children who had been exposed to three or more children for 10 or more hours per week than among those with less exposure (P=0.02) and were also greater among children with infection in both ears than among those with infection in one ear (P<0.001).
Conclusions
Among children 6 to 23 months of age with acute otitis media, reduced-duration antimicrobial treatment resulted in less favorable outcomes than standard-duration treatment; in addition, neither the rate of adverse events nor the rate of emergence of antimicrobial resistance was lower with the shorter regimen. (Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Research Resources; ClinicalTrials.gov number, NCT01511107 .).
PMID: 28002709 [PubMed – in process]
