A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Otitis Media
Intervention: cefdinir (Omnicef) (Drug); amoxicillin (Drug)
Phase: Phase 4
Sponsored by: Abbott
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: A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
Study design: Allocation: Randomized, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Clinical Cure Rate
Secondary outcome: Sustained Clinical Cure Rate
Minimum age: 6 Months.
Maximum age: 6 Years.
- 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
- 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
- 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
- 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.
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Vienna, Virginia 22180, United States
Starting date: February 2003
Last updated: March 21, 2008