Reducing Duration of Antibiotics Does More Harm than Good When Treating Ear Infections in Young Children

In a trial conducted at Children’s Hospital of Pittsburgh of UPMC and the University of Pittsburgh School of Medicine, researchers demonstrated that when treating children between 6 and 23 months of age with antibiotics for ear infections, a shortened course is less effective and did not reduce the risk of antibiotic resistance.

The results of the trial were published in the Dec. 22 issue of the New England Journal of Medicine.

Three of four children experience ear infections within their first year. Consequently, this painful inflammation of the middle ear, also known as acute otitis media, is the most common reason that children are prescribed antibiotics.

“Given significant concerns regarding overuse of antibiotics and increased antibiotic resistance, we conducted this trial to see if reducing the duration of antibiotic treatment would be equally effective along with decreased antibiotic resistance and fewer adverse reactions,” said lead author Alejandro Hoberman, MD, chief of the Division of General Academic Pediatrics at Children’s, and the Jack L. Paradise Endowed Professor of Pediatric Research at Pitt’s School of Medicine.

In the trial, 520 children with acute otitis media were randomly assigned to either a standard 10-day regimen of the antibiotic amoxicillin–clavulanate or a shortened five-day treatment followed by five days of placebo. Neither the study participants nor the physicians knew which group the participant was assigned to.

Researchers followed the children starting in October through the rest of the annual respiratory-infection season, and conducted a final visit during the following September.

They found that the risk of treatment failure in the five-day group was more than twice the risk as the 10-day group (34 percent versus 16 percent). Treatment failure was defined as worsening of symptoms or residual signs of infection upon examination.

They concluded, the 10-day treatment regimen was far more effective.

Additionally, when they tested for the presence of antibiotic-resistant bacteria using back of the nose swabs, there was no decrease in resistance in the five-day group as might have been expected. Reduced-duration antibiotics also did not decrease typical adverse events like diarrhea or diaper rash.

When testing the risk of a recurrent infection, the researchers found that it was higher when children were exposed to three or more children for 10 or more hours per week, such as in a day care setting, or if the initial infection occurred in both ears as opposed to just one ear.

The study also showed that almost one in two children with residual fluid in the middle ear after treatment had a recurring infection — a significantly higher percentage when compared to children without any residual fluid in the middle ear.

The marked superiority of the 10-day regimen over the five-day regimen led the independent safety monitoring board overseeing the trial to conclude it early.

“The results of this study clearly show that for treating ear infections in children between 6 and 23 months of age, a five-day course of antibiotic offers no benefit in terms of adverse events or antibiotic resistance. Though we should be rightly concerned about the emergence of resistance overall for this condition, the benefits of the 10-day regimen greatly outweigh the risks,” said Dr. Hoberman.