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Shortened antimicrobial therapy yields inferior efficacy among young children with AOM
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Young children treated with short-duration amoxicillin-clavulanate for acute otitis media experienced greater clinical failure compared with children treated over standard-duration, according to data published in New England Journal of Medicine.
Further, incidences of antimicrobial resistance and adverse events did not decrease with the shorter-duration regimen.
“A potential strategy for reducing the risk of antimicrobial resistance is to limit the duration of antimicrobial treatment,” Alejandro Hoberman, MD, from the department of pediatrics at the University of Pittsburgh School of Medicine and Children’s Hospital of Pittsburgh of the University of Pittsburgh Medical Center, and colleagues wrote. “Clinical trials that have compared reduced-duration treatment in children with acute otitis media have shown either no difference in outcome or modest differences that favor standard-duration treatment.”
The researchers sought to determine whether limiting antimicrobial treatment would produce similar outcomes and a decreased rate of incidence for developing antimicrobial resistance and adverse events. They conducted a two-site, 3-year trial including 520 children aged between 6 to 23 months with AOM assigned to receive amoxicillin-clavulanate for a standard duration of 10 days (n = 291) or for a reduced duration of 5 days (n = 229) followed by placebo for the remaining days. They performed assessments to evaluate the percentage of children who experienced clinical failure after treatment of index AOM.
Additionally, the researchers assessed symptom burden at days 6 to 14 of the index episode, rates of recurring AOM and outcomes in treating recurrence.
Analysis showed that children treated with amoxicillin-clavulanate for 5 days compared with children treated for the standard duration had greater rates of clinical failure (34% vs. 16%; 95% CI, 9-25). Moreover, mean symptom scores from day 6 to day 14 were 1.61 in the 5-day cohort and 1.34 in the 10-day cohort (P = .07).
Further, children in the 5-day cohort achieved lower decreased symptom scores of more than 50% compared with children in the 10-day cohort (P = .003); and clinical failure rates were greater among children exposed to three or more children for 10 or more hours each week (P = .02) and children with bilateral AOM (P < .001).
“In this noninferiority trial involving children 6 to 23 months of age with AOM, 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 prespecified non-inferiority margin,” the researchers wrote. “The difference in outcome between the two treatment groups also was large enough to show that standard-duration treatment was superior in efficacy to reduced-duration treatment.”
In a separate editorial, Margaret A. Kenna, MD, MPH, wrote that although a shorter duration of antibiotic therapy for AOM is desirable to reduce antibiotic resistance, decrease the risk for adverse outcomes, lower expenses and improve adherence, Hoberman and colleagues successfully demonstrated that the standard 10-day duration is superior to 5-day therapy for young children.
“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,” she wrote. – by Kate Sherrer
Disclosure: Hoberman 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 (U.S. patent application serial number, 14/371,731) and the development of a method and apparatus for aiding in the diagnosis of otitis media by classifying tympanic-membrane images (U.S. patent application serial number, 14/418,509). Hoberman and Martin report receiving consulting fees from Genocea Biosciences. All other researchers report no relevant financial disclosures.
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