A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Otitis Media
Intervention: cefdinir (Omnicef) (Drug); amoxicillin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Abbott
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 component), in divided doses, q12h for 10 days, in children between 6 months
and 6 years of age, with AOM.
Clinical Details
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: Treatment, Randomized, Single Blind (Investigator)
Primary outcome: Clinical Cure Rate
Secondary outcome: Sustained Clinical Cure Rate
Eligibility
Minimum age: 6 Months.
Maximum age: 6 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Ozark, Alabama 36360, United States
Montgomery, Alabama 36116, United States
Birmingham, Alabama 35211, United States
Scottsdale, Arizona 85251, United States
Mesa, Arizona 85201, United States
Little Rock, Arkansas 72211, United States
Fresno, California 93270, United States
Clovis, California 93612, United States
Longmont, Colorado 80501, United States
Fairfield, Connecticut 06430, United States
Marietta, Georgia 30062, United States
Stone Mountain, Georgia 30087, United States
Bardstown, Kentucky 40004, United States
Louisville, Kentucky 40207, United States
Owensboro, Kentucky 42301, United States
Ruston, Louisiana 71270, United States
Shreveport, Louisiana 71105, United States
Richland, Michigan 49083, United States
Kalamazoo, Michigan 49008, United States
Omaha, Nebraska 68178, United States
Las Vegas, Nevada 89104, United States
Columbus, Ohio 43205, United States
Medford, Oregon 97504, United States
Pittsburgh, Pennsylvania 15241, United States
Sellersville, Pennsylvania 18960, United States
Charleston, South Carolina 29403, United States
Lake Jackson, Texas 77566, United States
Austin, Texas 78758, United States
Salt Lake City, Utah 84121, United States
Salt Lake City, Utah 84109, United States
West Jordan, Utah 84084, United States
Vienna, Virginia 22180, United States
Additional Information
Starting date: February 2003
Last updated: March 21, 2008
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