The purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in the nose, and in the throat.
Pediatric patients with tympanostomy tubes were enrolled into one of two groups: 1) Treatment, i.e., patients with signs of otic infection, to be treated with CIPRODEX; or 2) Healthy, i.e., patients without signs of otic infection, to receive no treatment. Microbiological specimens were collected from four areas (ear canal, skin, nose, throat) during three study visits (Day 1, Day 8, and Day 42), and the specimens collected from the Healthy group served as a comparison (control) group for identifying fluoroquinolone (FQ) resistant bacterial strains.
Study Type
OBSERVATIONAL
Enrollment
318
Four drops in the outer ear canal of infected ear(s) while awake 2 times per day for 7 days
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
Change in microbial organism susceptibility and fluoroquinolone resistant flora at sites distal to the original infection.
Time frame: 42 + 10 days
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