By Beth Skwarecki
WebMD Health News
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 at two centers. The 5-day course did not result in any fewer cases of antibiotic-resistant infections or adverse events.
Alejandro Hoberman, MD, from the Department of Pediatrics at the University of Pittsburgh School of Medicine, Pennsylvania, and 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 definite diagnosis of acute otitis media seems to be a reasonable option," Margaret A. Kenna, MD, MPH, from the Department of Otolaryngology and Communication Enhancement and Boston Children's Hospital writes in an accompanying editorial.
The trial enrolled children between the ages of 6 and 23 months — the most likely age group to have treatment failure and recurrence. To be enrolled, the children had to have a diagnosis of acute otitis media based on three criteria: the presence of middle ear effusion, moderate or marked bulging of the tympanic membrane or slight bulging along with pain or redness, and a recent score of 3 or more on the 14-point Acute Otitis Media–Severity of Symptoms scale. Tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever are the criteria on that scale. All children had had at least two doses of pneumococcal conjugate vaccine.
Families were given two bottles of medicine: one of amoxicillin and clavulanate (90 and 6.4 mg/kg body weight) for the first 5 days and a second bottle containing either the same medicine or a placebo of the same color, texture, odor, and taste.
The investigators followed up with the child's family twice in the next 2 weeks and saw the child for visits every 6 weeks through the rest of the respiratory infection season. Whenever a child got another ear infection, they were treated with the same regimen as before (either 5 or 10 days). After two recurrences, however, or any time treatment failed, they were given a full 10-day dose of amoxicillin-clavulanate, ceftriaxone, or cefdinir.
Clinical failure was more common in the children receiving the 5-day course than in those receiving the 10-day course (34% vs 16%; difference of 17 percentage points; 95% confidence interval, 9 - 25 percentage points). To prevent one episode of clinical failure, the number needed to treat with a 10-day course is 6.
After the initial treatment, both groups of children had less penicillin-susceptible Streptococcus pneumoniae in their nasopharynx. Susceptible and nonsusceptible strains of Haemophilus influenzae remained the same. Adverse events were not significantly different between groups.
Aside from 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 if they initially presented with infections in both ears (P < 0.001).
The authors note that the results cannot be generalized to children older than the ones in this study.
Dr Kenna, who was not involved in the study, notes that a Cochrane review on this topic found that some studies showed no 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 outcomes measures, and did not directly compare the same drug in different durations.
Dr Hoberman and one coauthor report receiving consulting fees from Genocea Biosciences. Dr Hoberman also reports receiving grant support from Ricoh Innovations and holding pending patents related to the development of a reduced clavulanate concentration version of amoxicillin-clavulanate potassium and the development of a method and apparatus for aiding in the diagnosis of otitis media by classifying tympanic-membrane images. The remaining authors have disclosed no relevant financial relationships.
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SOURCE: Medscape, December 22, 2016. N Engl J Med. 2016;375:2446-2256, 2492-2493.
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