A five-day antimicrobial treatment regimen for middle ear infections in young children is inferior to the standard 10-day regimen, according to newly published research in The New England Journal of Medicine (NEJM). Middle ear infections (or “acute otitis media”) are common childhood illnesses often caused by bacteria and usually treated with antibiotics. However, overuse or inappropriate use of antibiotics (for example, to treat viral infections of the middle ear) can accelerate the emergence and spread of antimicrobial resistance. In the NEJM study, scientists from the University of Pittsburgh examined whether a shortened regimen worked as well as the standard 10-day treatment course for middle ear infection and also whether a shortened regimen reduced the risk of antimicrobial resistance. The research was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The trial enrolled 520 children aged 6-23 months diagnosed with middle ear infection using strict diagnostic criteria. Investigators randomly assigned the children to receive the antibiotic amoxicillin clavulanate for either 10 days or five days. Those in the five-day group then took a placebo for five additional days. The study was double-blind, meaning the researchers, clinicians and the children’s caregivers did not know which regimen each child was assigned. Investigators monitored the children’s symptoms and signs of infection during treatment and at follow-up visits after treatment ended.
The study found that 77 of 229 participants (34 percent) in the five-day treatment group experienced clinical failure, or a worsening of symptoms and signs of infection, as compared to 39 of 238 participants (16 percent) in the 10-day treatment group. Following treatment, researchers also examined bacteria samples from the children’s nose and throat cavities to study the presence of resistant bacteria. Although the investigators had expected that reducing the duration of antibiotic therapy would decrease the potential for antimicrobial resistance, there was no significant difference in levels of resistant bacteria between the two treatment groups. The authors conclude that the standard 10-day antibiotic regimen remains the preferred approach for treating middle ear infection.
A Hoberman et al. Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children. The New England Journal of Medicine DOI: 10.1056/NEJMoa1606043. (2016).
NIAID Director Anthony S. Fauci, M.D., is available for comment. Kristina T. Lu, Ph.D., program officer in the Respiratory Diseases Branch of NIAID’s Division of Microbiology and Infectious Diseases, is also available for comment.