A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

Study Overview
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Brief Summary
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The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.

Official Title
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A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

Conditions
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Acute Otitis Media

Intervention / Treatment
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* Drug: cefdinir (Omnicef)
* Drug: amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis, documented by medical history and physical examination, is acute otitis media <=1 week 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: Previous enrollment in this study. 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: cefdinir (Omnicef)<br>* oral suspension (7 mg/kg, ql2hr) for 5 days<br>* Other names: cefdinir;|
| Active Comparator: 2<br> | Drug: amoxicillin<br>* oral suspension (45 mg/kg/day, q l2 hours) for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure Rate |  | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Clinical Cure Rate |  | 28 days |