TAP Study

Tympanocentesis to Assess Pathogens Study

 

Protocol Description

This study is looking at the viruses and bacteria that are currently causing ear infections (AOM), including resistant bacteria. This research may help understand how infections are preventable by vaccines and enable development of adequate guidelines for treatment and vaccination.

Benefits

Children, with ear infections, enrolled in the study will have careful monitoring and follow-up for their ear infection through resolution of the episode. Children, with cold symptoms, enrolled in the study will have the benefit of close monitoring of their symptoms. Children, who have tympanocentesis, may experience relief from pain following fluid collection since this relieves the pressure behind the ear drum and helps the doctors decide what is the best antibiotic for your child. There are no charges for visits and adequate antibiotic treatment for the ear infection will be prescribed. The study team is available by phone; 24 hours a day.

Eligibility Criteria

Subject to certain exclusion criteria. This study is open to children ages 6-35 months, who have been diagnosed with an ear infection or have had cold symptoms for 72 hours or less.

Requirements

This study will have two visits; an enrollment visit and a follow-up visit. We will also see your child as needed if he/she is not feeling well between study visits. For all children enrolled in the study, we will perform an ear exam, take a picture of the ear drum and collect a nasal swab. We will also ask you to complete a daily diary of symptoms. Some children with more severe infections as evidenced by bulging eardrums and symptoms will have a procedure known as tympanocentesis. Tympanocentesis is done by making a small opening in the eardrum with a needle and drain the pus to relieve pressure immediately. We may ask some participants for a urine and/or blood sample.

Status: Open to Enrollment

Source(s) of Support

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Primary Investigator

Alejandro Hoberman, MD
Judith Martin, MD

Contact Information

For additional information or to enroll, please contact 412-692-7382.