Children’s Hospital of Pittsburgh of UPMC Study Finds Antibiotics Relieve Ear Infections in Kids Younger Than 2

January 12, 2011

Antibiotics are an effective treatment for young children with acute middle ear infections, according to a clinical trial at Children’s Hospital of Pittsburgh of UPMC. The findings add important new evidence to the best treatment for ear infections and could have major implications on treatment guidelines in the United States.

Results of the study are published in the Jan. 13 issue of the New England Journal of Medicine.

The researchers found that in children ages 6 months to 2 years with acute otitis media (AOM), or middle ear infection, treatment with antibiotics for 10 days reduced the severity and duration of the infections more effectively than placebo, according to principal investigator Alejandro Hoberman, M.D., chief of the Division of General Academic Pediatrics and vice chair of Clinical Research at Children’s Hospital. Children in the study who received antibiotics also were less likely to have evidence of clinical failure (persistent signs of acute infection) that required further treatment, Dr. Hoberman said.

“Based on these findings, there is strong evidence in favor of treating children younger than 2 years of age with antibiotics, irrespective of the severity of the ear infection,” said Dr. Hoberman, also a professor of pediatrics in the University of Pittsburgh School of Medicine. “To some degree, this is contrary to current clinical guidelines, which include an option for watchful waiting rather than prompt treatment for young children with apparently mild symptoms. We expect our study to have an impact on treatment guidelines for the United States that currently are being revised.”

For children with mild symptoms and for whom diagnosis of AOM is uncertain, a watchful waiting strategy is included in current U.S. guidelines jointly developed by the American Academy of Pediatrics and the American Academy of Family Physicians. Watchful waiting also is included in Canadian guidelines without reference to diagnostic certainty, and has been applied in some European countries for many years, according to Dr. Hoberman.

“However, these recommendations are based on studies with many important limitations, most notably, a lack of strict diagnostic criteria,” he said. “In other words, many of the children studied merely may have had fluid in the middle ear instead of an actual ear infection. Other limitations were the inclusion of few very young children, in whom the infection tends to be more stubborn, and the use of antibiotics that had a limited effectiveness or were given in doses that were ineffective.”

Dr. Hoberman’s study randomly assigned 291 children between 6 months and 2 years of age to receive either the antibiotic amoxicillin-clavulanate or a placebo for 10 days.

An improvement in symptoms occurred earlier in children who received antibiotics. Mean symptom scores over the first seven days were lower at each time point in the antibiotic group than in the placebo group. Larger differences between children receiving the antibiotic and children receiving the placebo were observed in rates of clinical failure: 4 percent vs. 23 percent on day four or five; and 16 percent vs. 51 percent on days 10 to 12.

The key to optimal management of AOM remains an accurate diagnosis, according to Dr. Hoberman.

“Young children with a certain diagnosis of AOM are more likely to recover when treated with an appropriate antibiotic, and their symptoms will subside more quickly,” he said. “Provided the diagnosis of AOM in children younger than 2 years of age is certain, we favor treatment with antibiotics.”

This study was funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

For more information about Dr. Hoberman’s research, visit

Marc Lukasiak, 412-692-7919,
Anita Srikameswaran, 412 578-9193,