A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
NCT ID: NCT00645112
Last Updated: 2008-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
357 participants
INTERVENTIONAL
2003-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
cefdinir (Omnicef)
oral suspension, 7 mg/kg every 12 hours for 5 days
2
azithromycin
oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.
Interventions
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cefdinir (Omnicef)
oral suspension, 7 mg/kg every 12 hours for 5 days
azithromycin
oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical symptoms include \>=1 of the following: Otalgia (earache or pain), this may be expressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may be based on reports from parents or legally authorized representatives; Discharge from the 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 or bulging or perforated tympanic membrane, which may be erythematous (note - since hyperemia may be present in a febrile or crying child, a red tympanic membrane alone is insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks (opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membrane and edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated by acoustic reflect tympanometry (ear check) showing values of 3, 4 or 5.
* Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results.
* Subject must be a suitable candidate for oral antibiotic therapy.
Exclusion Criteria
* Enrollment in any other investigational study using unapproved products or unapproved doses; in the previous four weeks prior to study start.
* Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, other macrolide 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 1 or during the study.
* Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G benzathine) 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 with resolution of this episode of acute otitis media.
* Immunocompromised subject (e.g., neutropenic subjects).
* Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.
* Any expectation that treatment with probenecid will be expected during the study drug administration period.
* Known significant renal or hepatic impairment.
6 Months
6 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Columbiana, Alabama, United States
Montgomery, Alabama, United States
Ozark, Alabama, United States
Fresno, California, United States
Fresno, California, United States
Marietta, Georgia, United States
Stone Mountain, Georgia, United States
Dubuque, Iowa, United States
Bardstown, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Cadillac, Michigan, United States
Kalamazoo, Michigan, United States
Portage, Michigan, United States
Richland, Michigan, United States
Omaha, Nebraska, United States
Columbus, Ohio, United States
Huber Heights, Ohio, United States
Pittsburgh, Pennsylvania, United States
Reading, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Charleston, South Carolina, United States
Kingsport, Tennessee, United States
Lake Jackson, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
West Jordan, Utah, United States
Vienna, Virginia, United States
Monroe, Wisconsin, United States
Countries
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Other Identifiers
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M03-630
Identifier Type: -
Identifier Source: org_study_id