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



Status:Completed
Conditions:Healthy Studies, Other Indications, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:December 2009
End Date:November 2012
Contact:Alcon Call Center
Phone:1-888-451-3937

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


Study conducted to evaluate possible formation/growth of antibiotic resistant bacteria at
distal sites.


Inclusion Criteria:

- participants must be at least 6 months old up to 5 years of age at the time of
enrollment with patent bilateral tympanostomy tubes. Enrollment includes healthy
subjects (no incidence of otorrhea) or infected patients with 21 days or less of
otorrhea in at least one ear. Parent must read/sign informed consent and comply with
requirement of the study.

Exclusion Criteria:

- Pediatric patients are excluded if presents with acute otitis media (AOE), malignant
otitis externa (MOE), suspected ear infection of fungal or mycobacterial origin.
Participants are excluded if they have diabetes, prior otologic surgery, mastoiditis,
immunosuppressive disorders, anatomical structural disorders, suspected infections
requiring systemic antibiotic therapy, chronic nasal obstructions, concomitant use of
topical or oral analgesics, hypersensitivity to quinolones, or a history of herpes
simplex, vaccina or varicella infections of the tympanic membrane.
We found this trial at
1
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6201 South Freeway
Fort Worth, Texas 76134
800 862 5266
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