Phase
Condition
Ear Infections
Otitis Media
Ear Infections (Pediatric)
Treatment
N/AClinical Study ID
Ages 6-6 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Clinical diagnosis, documented by medical history and physical examination, is AOM I 1week.
Clinical symptoms include >=1 of the following: Otalgia (earache or pain), this may beexpressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may bebased on reports from parents or legally authorized representatives; Discharge fromthe external auditory canal (following acute perforation of the tympanic membrane).
At least two (2) of the following signs are present in at least one ear: Full orbulging or perforated tympanic membrane, which may be erythematous (note - sincehyperemia may be present in a febrile or crying child, a red tympanic membrane aloneis insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks (opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasicpneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membraneand edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated byacoustic reflect tympanometry (ear check) showing values of 3, 4 or 5.
Generally in good health based on medical history, vital signs, physical exam, andhistorical laboratory results.
Subject must be a suitable candidate for oral antibiotic therapy.
Exclusion
Exclusion Criteria:
Previous enrollment in this study.
Enrollment in any other investigational study using unapproved products or unapproveddoses; in the previous four weeks prior to study start.
Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, othermacrolide and azalide antibiotics, and/or sensitivity to multiple allergens.
Presence of tympanostorny tubes or otitis externa at Evaluation 1.
Systemic treatment with any anti-infective agent within 14 days prior to Evaluation 1or during the study.
Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin Gbenzathine) within 4 weeks prior to study drug administration.
Concomitant infection that requires additional antimicrobial therapy.
Evidence of chronic, suppurative otitis media.
Evidence of perforation of the tympanic membrane > 24 hours.
Evidence of a physiologic, anatomic, or immunologic defect, which would interfere withresolution of this episode of acute otitis media.
Immunocompromised subject (e.g., neutropenic subjects).
Presence of a disease, complicating factor (e.g., mastoiditis), or structuralabnormality that would preclude evaluation of the subject's therapeutic response.
Any expectation that treatment with probenecid will be expected during the study drugadministration period.
Known significant renal or hepatic impairment.
Study Design
Connect with a study center
Columbiana, Alabama 35051
United StatesSite Not Available
Montgomery, Alabama 36116
United StatesSite Not Available
Ozark, Alabama 36360
United StatesSite Not Available
Fresno, California 93710
United StatesSite Not Available
Marietta, Georgia 30062
United StatesSite Not Available
Stone Mountain, Georgia 30087
United StatesSite Not Available
Dubuque, Iowa 52002
United StatesSite Not Available
Bardstown, Kentucky 40004
United StatesSite Not Available
Louisville, Kentucky 40207
United StatesSite Not Available
Owensboro, Kentucky 42303
United StatesSite Not Available
Cadillac, Michigan 49601
United StatesSite Not Available
Kalamazoo, Michigan 49008
United StatesSite Not Available
Portage, Michigan 49024
United StatesSite Not Available
Richland, Michigan 49083
United StatesSite Not Available
Omaha, Nebraska 68178
United StatesSite Not Available
Columbus, Ohio 43205
United StatesSite Not Available
Huber Heights, Ohio 45424
United StatesSite Not Available
Pittsburgh, Pennsylvania 15241
United StatesSite Not Available
Reading, Pennsylvania 19606
United StatesSite Not Available
Sellersville, Pennsylvania 18960
United StatesSite Not Available
Charleston, South Carolina 29425
United StatesSite Not Available
Kingsport, Tennessee 37664
United StatesSite Not Available
Lake Jackson, Texas 77566
United StatesSite Not Available
Salt Lake City, Utah 84109
United StatesSite Not Available
West Jordan, Utah 84008
United StatesSite Not Available
Vienna, Virginia 22180
United StatesSite Not Available
Monroe, Wisconsin 53566
United StatesSite Not Available
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