Trial Information

Ear Infections (Pediatric)

The purpose of this research study is to compare the effectiveness and potential side effects of the experimental drug called ciprofloxacin plus fluocinolone acetonide otic solution, or “Cetraxal Plus,” against the active ingredients alone (ciprofloxacin and fluocinolone acetonide) in treating ear infections.

Patient Inclusion Criteria:

Patient of either sex between 6 months and 12 years of age (both inclusive)
Patients with patent tympanostomy tube in the ear which will be treated (must be present and open)
Patients suffering from otorrhea for 3 weeks or less
Signed informed consent from the patient’s legally authorized representative; also, if the patient is capable of providing assent, signed assent from the patient.

Patient Exclusion Criteria:

Tympanostomy tube placement 3 days or less before study entry
Tympanostomy tubes containing antiseptic or antibacterial activity (silver oxide or silver salts), T-type tubes
Acute otitis externa or malignant otitis externa
Otologic surgery within the previous year (other than tympanostomy tube placement)
Acute or chronic renal disease, active hepatitis
Chronic nasal obstruction and/or persistent rhinorrhea
Craniofacial anomalies
Patient predisposed to neurosensory hearing loss*
Use of topical or otic steroids within 3 days of enrollment or systemic steroids within 7 days of enrollment
Use of intranasal or inhaled steroids within 3 days of enrollment

Paul Koros, RN, Site Manager
NEA Baptist Clinic - Clinical Research Center
416 E. Washington, Suite C
Jonesboro, AR 72401
Phone: 870-934-1006
Fax: 870-934-1008
Email: paul.koros@neabaptistclinic.com

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Research Center Information: NEA Baptist Clinic - Clinical Research Center

If you would like to learn more about participating in this study, please send an email message using the form below.

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