Clinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR in the body after it has been swallowed by children.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
amoxicillin/clavulanate potassium
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
North Dartmouth, Massachusetts, United States
GSK Investigational Site
Sylva, North Carolina, United States
Pharmacokinetic data on amoxicillin/clavulanate
Time frame: Time above MIC (T>MIC)for amoxicillin when amoxicillin/clavulanate is given orally twice daily to adolescents.
Safety, tolerability, and clinical response of oral amoxicillin/clavulanate
Time frame: twice daily for 10 days in adolescent patients.
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GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Erie, Pennsylvania, United States