All children younger than 2 with acute otitis media diagnosed according to current American Academy of Pediatrics guidelines should receive antibiotics, researchers said.
Among children age 6 months to 2 years with unilateral, nonsevere acute otitis media given amoxicillin-clavulanate, treatment failures were seen in 14% compared with failure rates of 40% in those given placebo, for an adjusted relative risk of 0.27 (95% CI 0.13-0.41), according to Alejandro Hoberman, MD, of the University of Pittsburgh, and colleagues.
In contrast, children with bilateral, severe otitis media - those for whom treatment currently is recommended - had failure rates of 25% with antimicrobial treatment and 59% with placebo, giving an adjusted relative risk of 0.34 (95% CI 0.18-0.48), Hoberman and colleagues wrote online in a research letter in JAMA Pediatrics.
“A recent American Academy of Pediatrics guideline recommends prompt antimicrobial treatment for children ages 6 months to 2 years with acute otitis media, with one exception: for children in whom the disease is unilateral and also unaccompanied by severe signs or symptoms, the guideline recommends, as an option, observation without initial antimicrobial therapy,” they observed.
However, that recommendation was based on studies that used diagnostic criteria that were less strict than the current requirements, opening the possibility that some treated children didn’t actually have acute otitis media.
To clarify this, the researchers pooled data from two previously published trials, one conducted in Pittsburgh and the other in Turku, Finland, both of which had stringent requirements for enrollment that came close to guaranteeing valid diagnoses.
The Pittsburgh trial defined treatment failure as inadequate symptomatic or otoscopic improvement by day 4 or 5 and incomplete resolution by days 10 to 12.
The Turku study defined treatment failure as a lack of overall improvement by day 3, no improvement in otoscopic findings by day 8, and the occurrence at any time of overall clinical deterioration, perforation of the tympanic membrane, or treatment discontinuation.
All children younger than 2 with acute otitis media diagnosed according to current American Academy of Pediatrics guidelines should receive antibiotics.
Point out that the current study is based on a pooled review of studies among children 6 months to 2 year whose infection was unilateral and/or whose illness was non-severe showing that those treated with placebo had higher rates of treatment failure compared with those treated with amoxicillin-clavulanate.
The otitis media was classified as severe if the parents described the ear pain as moderate or severe or if the child had had a temperature of 39 degrees C.
In general, treatment failure rates were similar for severe and nonsevere disease and for unilateral and bilateral involvement.
For those with unilateral severe disease, treatment failure rates were 14% for the treated group and 47% for the placebo group, with an adjusted relative risk of 0.34 (95% CI 0.18-0.50), while the rates for bilateral nonsevere disease were 22% and 53%, respectively, for an adjusted relative risk of 0.31 (95% CI 0.14-0.48).
The numbers needed to treat were:
Unilateral nonsevere, 4
Unilateral severe, 3
Bilateral nonsevere, 4
Bilateral severe, 3
“These findings make a case for a uniform approach to antimicrobial treatment in children younger than 2 years with stringently diagnosed [acute otitis media], irrespective of laterality or apparent severity of their illness,” Hoberman and colleagues stated.
The study had no external funding. The authors reported no conflicts of interest.
By Nancy Walsh, Staff Writer, MedPage Today