Research

Treatment of Acute Otitis Media (AOM), 10 versus 5 Days of Antibiotics

Efficacy of Short-Course Antimicrobial Treatment for Young Children With Acute Otitis Media and Impact on Antimicrobial Resistance

Protocol Description

View an overview of the study by Alejandro Hoberman, MD.

This study, funded by the National Institutes of Health (NIH), will help determine whether children ages 6 to 23 months diagnosed with an ear infection (AOM) can be effectively treated with antibiotics for 5 days rather than 10. A shorter treatment course may be beneficial in 1) reducing the likelihood of side effects, the most common being diaper rash and diarrhea, and 2) reducing antibiotic resistance, which occurs when bacteria change in a way that makes it harder to be killed by antibiotics.

Benefits
Children enrolled in the study will have careful monitoring and follow-up for ear infections. There are no charges for visits or study medications. The clinical team is available by phone, 24 hours a day, and will see study participants whenever parents have concerns that the child may have another ear infection.

Eligibility Criteria

This study is open to children, ages 6 through 23 months, who have been diagnosed with AOM during the respiratory season (October 1 through March 31), for whom treatment has not yet been initiated.

Requirements

Enrollment visit between October 1 and March 31
A follow-up visit 2 weeks after enrollment
Doctors and nurse practitioners, who are experts at looking at young children’s ears, will follow children carefully every 6 weeks until May 31
Final visit will occur in September

Status: Open for Enrollment

Source of Support
National Institute of Allergy and Infectious Diseases, NIH

Additional Information
Study description at National Institutes of Health