Acute Otitis Media (AOM) Therapy Trial in Young Children
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to learn whether or not all children with ear infections (acute
otitis media or AOM) should be treated with antibiotics. The study will compare two treatment
strategies, "watchful waiting" or treatment with antibiotics, to determine which is more
appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23
months, with AOM will be enrolled in the study. They will be treated either with Augmentin
(an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will
be asked to write information about their child in a Patient Diary. A general physical exam,
including an ear exam, will be performed 4 times during the study. A mucus sample will be
collected from the back of each child's nose. Parents will be asked questions during phone
calls and at every visit. If a child has not improved or has worsened, the investigators will
prescribe a different antibiotic that is known to kill resistant germs.
Phase:
Phase 4
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)