Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
Status:
Completed
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
Summary
To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced
concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered
at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided
doses for 10 days. Investigators will focus on the proportion of subjects who develop
protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the
prescription of antifungal medication.