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Antibiotics benefit infants and young children with certain diagnosis of AOM
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Infants and young children with a certain diagnosis of acute otitis media recover more quickly when they are treated early with an antimicrobial agent that gives adequate coverage, according to the findings of two studies published online today.
In the first study, Infectious Diseases in Children Editorial Board member Alejandro Hoberman, MD, and colleagues from the University of Pittsburgh School of Medicine concluded that in a cohort of 291 children aged 6 to 23 months, initial treatment with amoxicillin–clavulanate for 10 days reduced resolution time and overall symptom burden compared with placebo. In the second study, led by Paula A. Tähtinen, MD, and colleagues from Turku University Hospital, the researchers noted treatment failure in 18.6% of children who received amoxicillin–clavulanate for AOM compared with 44% in a placebo arm.
“Since the physician cannot determine at the onset of the illness which child is likely to benefit from antimicrobial therapy, we need to consider these data as applicable to all young children in whom a certain diagnosis of acute otitis media has been made,” Infectious Diseases in Children Editorial Board member Jerome Klein, MD, wrote in a guest editorial that was published alongside the two papers in The New England Journal of Medicine.
Strict AOM definitions
Both clinical trials used strict definitions of AOM, which said children who were enrolled in the studies were defined by “acute onset of the condition and the presence of middle-ear effusion, as well as a bulging tympanic membrane, and otalgia or erythema of the tympanic membrane.” Both studies used experienced otoscopists to assess AOM.
In the trial by Hoberman and colleagues, children were randomly assigned to receive a 10-day course of amoxicillin-clavulanate or placebo. The researchers said 35% of the antibiotic group were experiencing symptom relief by day 2, 61% by day 4 and 80% by day 7 vs. 28%, 54% and 74% in the group that was observed initially (P=0.14 for the overall comparison).
Clinical failure rates, which the researchers defined as the persistence of signs of acute infection on otoscopic examination at day 4 or 5, were also higher in the observation group — 23% vs. 4% in the antibiotic group (P<.001). Sustained symptom relief rates were also better in the early antibiotic group (P=.04 for the overall comparison).
In the second study, Tähtinen and colleagues randomly assigned 161 children to receive a 7-day course of amoxicillin-clavulunate and 158 to receive placebo, and they assessed treatment failure on day 8. Researchers defined treatment failure based on the overall condition of the child, including adverse events, otoscopic signs and AOM.
The researchers noted treatment failure in 18.6% of the children who received amoxicillin-clavulanate vs. 44.9% of the placebo group (P<.001). Even as early as day 3, the researchers observed differences between the two groups, with treatment failure noted in 13.7% of the antibiotic group and 25.3% of the placebo group.
Both studies noted more diarrhea in the antibiotics groups.
Needed data
In his editorial, Klein said earlier trials that endorsed the practice of watchful waiting for AOM had substantial design flaws, “including the lack of precise criteria for the diagnosis of acute otitis media, participation of physicians who were not validated otoscopists, inadequate sample size, inclusion of older children, inclusion of children who had minimal or uncertain signs of disease, and ambiguous end points for cure or failure.”
Nevertheless, Klein said, in 2004, the AAP endorsed the practice of initial observation as an option for children 6 to 23 months of age who have nonsevere illness and an uncertain diagnosis, which led to some controversy about the best AOM management approach.
The key to best AOM management is accurate diagnosis, Klein told Infectious Diseases in Children, adding that the AAP criteria for diagnosis of AOM were followed by the investigators in the two studies and should be the gold standard for diagnosis of AOM for all physicians who care for children.
“Is acute otitis media a treatable disease,” Klein wrote in the NEJM editorial. “The investigators in Pittsburgh and Turku have provided the best data yet to answer the question.” – by Colleen Zacharyczuk
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Disclosures: The trial by Hoberman and colleagues was funded by the National Institute of Allergy and Infectious Diseases. Dr. Hoberman reported receiving honoraria and travel-expense reimbursement from GlaxoSmithKline. The Finnish trial was funded by the Foundation for Pediatric Research and others.
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