A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
NCT ID: NCT00644943
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
425 participants
INTERVENTIONAL
2003-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
SINGLE
Study Groups
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1
cefdinir (Omnicef)
oral suspension (7 mg/kg, ql2hr) for 5 days
2
amoxicillin
oral suspension (45 mg/kg/day, q l2 hours) for 10 days
Interventions
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cefdinir (Omnicef)
oral suspension (7 mg/kg, ql2hr) for 5 days
amoxicillin
oral suspension (45 mg/kg/day, q l2 hours) for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical signs and symptoms include \>=1 of the following: ear pain; ear fullness, decreased hearing, or discharge from the external auditory canal (following acute perforation of the tympanic membrane).
* At least two of the following conditions are present in at least one ear: bulging tympanic membrane, which may have redness; loss of the normal light reflex and tympanic membrane landmarks and abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind it and edema of the tympanic membrane.
* Have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry.
* Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results
Exclusion Criteria
* Enrollment in any other investigational study using unapproved products or unapproved doses, including investigational vaccines in the previous four weeks prior to study start.
* Hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, other drugs, and/or sensitivity to multiple allergens.
* Presence of tympanostomy tubes or otitis externa at Evaluation 1.
* Systemic treatment with any anti-infective agent within 7 days (14 days for azithromycin) 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 a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.
* Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.
* Known, severe renal impairment (i.e., creatinine clearance \< 30 mUmid1.73 m2).
* History of Augmentin-associated cholestatic jaundicehepatic dysfunction.
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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Birmingham, Alabama, United States
Montgomery, Alabama, United States
Ozark, Alabama, United States
Mesa, Arizona, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Clovis, California, United States
Fresno, California, United States
Longmont, Colorado, United States
Fairfield, Connecticut, United States
Marietta, Georgia, United States
Stone Mountain, Georgia, United States
Bardstown, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Ruston, Louisiana, United States
Shreveport, Louisiana, United States
Kalamazoo, Michigan, United States
Richland, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Columbus, Ohio, United States
Medford, Oregon, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Lake Jackson, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Vienna, Virginia, United States
Countries
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Other Identifiers
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M02-541
Identifier Type: -
Identifier Source: org_study_id