A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections

summary of baseline susceptibilities

Time frame: Study endpoint

clinical response (cure or failure) in the Clinical Per Protocol population

Time frame: On-Treatment (OT) visit (Day 4-6)

Laboratory abnormalities

Time frame: Baseline and TOC visit

bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population

Time frame: TOC visit

adverse events

Time frame: Continuous

clinical response (cure or failure) in all populations except the Clinical Per Protocol population

Time frame: OT visit and TOC visit

clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population

Time frame: OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32)

clinical response (cure or failure) in the Clinical Per Protocol population

Time frame: LTFU visit

clinical scores for the Clinical Per Protocol population

Time frame: OT visit and TOC visit