Status:
COMPLETED
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
Lead Sponsor:
Abbott
Conditions:
Acute Otitis Media
Eligibility:
All Genders
6-6 years
Phase:
PHASE4
Brief Summary
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 co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT00644943
Start Date
February 1 2003
Last Update
March 27 2008
Active Locations (32)
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1
Birmingham, Alabama, United States, 35211
2
Montgomery, Alabama, United States, 36116
3
Ozark, Alabama, United States, 36360
4
Mesa, Arizona, United States, 85201