A 10-day course of antibiotics worked better than a 5-day course for young children with ear infections in a randomized controlled trial of 520 children in two centers. The 5-day course did not result in fewer cases of antibiotic-resistant infections or adverse events.
Alejandro Hoberman, MD, of the Department of Pediatrics at the University of Pittsburgh School of Medicine, Pennsylvania, and his colleagues report their findings in an article published in the December 22 issue of the New England Journal of Medicine.
“For now, 10 days of amoxicillin-clavulanate for children younger than 2 years of age who have a definitive diagnosis of acute otitis media seems to be a reasonable option,” Margaret A. Kenna, MD, MPH, Department of Otorhinolaryngology and Communication Enhancement And the Children’s Hospital of Boston writes in an accompanying editorial.
The trial included children between the ages of 6 and 23 months – the age group most likely to have treatment failure and recurrence. To be enrolled, children had to have a diagnosis of acute otitis media, based on three criteria: presence of middle ear effusion, moderate bulging or tympanic membrane marking or slight bulging together with pain or redness and a recent score of 3 or more on the 14-point scale of acute otitis media symptom severity.
Ears, tears, irritability, difficulty sleeping, decreased activity, decreased appetite and fever are the criteria to that scale. All children had had at least two doses of pneumococcal conjugate vaccine.
The families were given two medicine bottles: one of amoxicillin and clavulanate (90 and 6.4 mg / kg body weight) during the first 5 days and a second containing the same drug or a placebo of the same color, texture , Smell and taste.
The researchers followed the child’s family twice in the next 2 weeks and saw the child for visits every 6 weeks for the remainder of the respiratory infection season. Each time a child has another ear infection, they were treated with the same regimen as before (either 5 or 10 days). After two relapses, however, or at any time treatment failed, they were given a full 10-day dose of amoxicillin-clavulanate, ceftriaxone, or cefdinir.
Clinical failure was more common in children who received the 5-day course than in those who received the 10-day course (34% vs. 16%, difference of 17 percentage points, 95% confidence interval, 9-25 points Percentages). To avoid an episode of clinical failure, the number needed to treat a 10 day course is 6.
After initial treatment, both groups of children had less penicillin-susceptible Streptococcus pneumoniae in their nasopharynx. Strains susceptible and not susceptible to Haemophilus influenzae remained the same. Adverse events were not significantly different between groups.
In addition to treatment, children were more likely to have clinical failure if they spent more than 10 hours per week with at least three other children (P = 0.02) and initially had infections in both ears (p <0.001). The authors note that the results can not be generalized to children older than those in this study.
Dr. Kenna, who did not participate in the study, points out that a Cochrane review on this topic found that some studies did not show a difference between long and short courses of antibiotics but that many of those studies were not blinded, did not use strict criteria for Diagnosis or outcome measures, and did not directly compare the same drug in different durations.
Dr Hoberman and a co-author report receiving consulting fees from Genocea Biosciences.