NCT01027494

Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora

Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora Distal to the Site of Infection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 318 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 6 Months – 4 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Otitis Media

Interventions

Type	Name	Description
DRUG	Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension	Four drops in the outer ear canal of infected ear(s) while awake 2 times per day for 7 days

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2009-12-08
• Last updated: 2013-03-18

Locations

1 site across 1 country: United States