- Otitis media affects three in four children below 3 years of age.
- A standard 10-day antibiotic regimen offers improved clinical outcome in children with ear infections.
- The risk of treatment failure in the shortened 5-day antibiotic regimen was 34% higher than the 10-day regimen.
An antibiotic course of shortened duration did not improve the clinical outcomes or reduce the risk of antibiotic resistance and side-effects in children suffering from ear infections.
The researchers have demonstrated the results in children between 9 and 23 months of age.
‘The benefits of 10-day antibiotic regimen for acute ear infection in children greatly outweigh the risks.’
Otitis media is a bacterial infection of the middle ear behind the ear drum which causes it to become inflamed and painful. It occurs in children below the age of 3 years.Three out of four children experience this infection within their first year.
There are two main types-
- acute otitis media (AOM) where the ear becomes infected and painful.
- otitis media with effusion (OME) where the fluid and mucus stay trapped even after the infection has subsided.
It is one of the most common reason why children are prescribed an antibiotic.
"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 Alejandro Hoberman, M.D., chief, 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 double blind trial, where neither the children nor the physicians knew which group the participant was being assigned to, 520 children with acute otitis media were randomly assigned.
They were assigned with a standard 10-day regimen of the antibiotic amoxicillin-clavulanate or a shortened 5-day treatment followed by placebo for five days.
Children were followed from October through the rest of the annual respiratory-infection season.
Risk of Infection Higher In 5-Day Group
The researchers found that the risk of treatment failure in the 5-day group was at 34%, which was more than twice as much the risk in the 10-day group at 16%.
The results clearly showed that the 10-day treatment was far more effective.
Also there was no decrease either in the adverse effects of antibiotic use like diarrhea or diaper rash in the 5-day group or in the presence of antibiotic-resistant bacteria that were tested through nasopharyngeal (back of the nose) swabs.
The researchers found that the risk of recurrent infection was higher:
- Among children who were exposed to other children with the infection in places like day-care setting.
- If the initial infection occurred in both ears.
- If residual fluid was observed in the middle ear after treatment.
"The results of this study clearly show that for treating ear infections in children between 9 and 23 months of age, a 5-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.
The trial was conducted at Children's Hospital of Pittsburgh of UPMC and the University of Pittsburgh School of Medicine and the results of the trial are published in the New England Journal of Medicine
- Otitis Media/ Middle Ear Infection - (http://www.medindia.net/patients/patientinfo/otitismedia.htm)
- Alejandro Hoberman et al. Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children. New England Journal of Medicine; (2016) DOI: 10.1056/NEJMoa1606043