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

Protocol Description

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: Closed to Enrollment

Source(s) of Support

National Institute of Allergy and Infectious Diseases, NIH

Additional Information

Study description at National Institutes of Health

Published Findings

• Study Article in the New England Journal of Medicine
• Quick Video Summary of the Study
• Interview with Dr. Hoberman

Primary Investigator

Alejandro Hoberman, MD

Contact Information

For information or to enroll, please contact:
412-999-EARS (3277)