Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children
“Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children” The New England Journal of Medicine. 2016; 375: 2446-56.
Aside from the common cold, acute otitis media is the most frequently diagnosed illness in children in the United States and currently is the most common indication for antimicrobial treatment. Previous studies have shown a clear benefit of 7-10 days of antibiotic therapy when compared to placebo in treating children less than 3 years of age with AOM. With growing concern for antibiotic resistance, this non-inferiority study aimed to determine if a 5-day course of augmentin (amoxicillin-clavulanate) is comparable to the standard 10-days regimen.
Randomized controlled trial from January 2012-September 2015 at Children’s Hospital of Pittsburgh and affiliated pediatric practices, and Kentucky Pediatric and Adult Research, enrolled 520 children with AOM to receive either 10 days of augmentin or 5 days of augmentin followed by 5 days of placebo ( matched in terms of color, texture, taste and odor). Eligible patients were age 6-23 months who had received 2+ doses of pneumococcal vaccine, were diagnosed with AOM within 48 hours (middle ear effusion + bulging tympanic membranes by physicians who completed an otoscope validation program), and had an AOM-SOS (AOM-Severity of Symptoms) score greater than 3. Children were excluded if they had already had perforation, had another illness at the time, if they had a penicillin allergy, or if they had received a dose of antibiotics within the last 96 hours. The groups were stratified based on age and whether or not they had been around 3+ kids for an average of 10+ hours per week.
The primary outcome was clinical failure (worsening otoscope findings or incomplete resolution of symptoms). Secondary outcomes were recurrences of AOM, symptom burden as measured by the AOM-SOS scale, pathogen colonization, adverse events (diarrhea and dermatitis from the augmentin), use of other health-care services, rates of missed work or need for specialized childcare, and parent satisfaction on a 5-point scale. The AOM-SOS score was recorded daily by the parents, and the participants were monitored at day 4-6 via a physician phone call and at day 12-14 with an in-person treatment follow-up visit.
Clinical failure was found in 34% of the patients in the 5-day treatment group as compared to 16% in the 10-day regimen. The confidence interval for this finding was 9-25% which exceeded the predetermined acceptable upper-limit. Clinical failure was found to be more common in kids who had AOM affecting both ears or had been exposed to 3+ kids for 10+ hours per week. By day 12-14 there was a statistically significant difference in mean AOM-SOS scores between the 5-day (1.89) and 10-day (1.20) treatment groups.
There was also a significant difference in the number of patients who reported at least a 50% decrease of symptoms (80% in the 5-day group versus 91% in the 10-day group). However, there were no difference in the rates of recurrence, likelihood of residual middle-ear effusions, rates of colonization (even with penicillin resistant pathogens), adverse events, use of health-care services, days missed of work or need for specialized childcare, or parental satisfaction. Children from both groups were more likely to have a recurrence of disease if they had a residual effusion.
A 5-day course of augmentin leads to increased rates of clinical failure and less patients reporting a decrease in symptoms, with no change in rates of recurrence, colonization, or adverse events from the medication. All kids under age 2 presenting with AOM should be given a 10-day course of antibiotics.