A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin 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); azithromycin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Abbott
Summary
To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5
days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a
total of 5 days, in children between 6 months and 6 years of age, with AOM.
Clinical Details
Official title: A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Clinical cure rate at Evaluation 2
Secondary outcome: Sustained clinical cure rate at Evaluation 4
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 AOM I
1 week.
- Clinical symptoms include >=1 of the following: Otalgia (earache or pain), this may
be expressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may be
based on reports from parents or legally authorized representatives; Discharge from
the external auditory canal (following acute perforation of the tympanic membrane).
- At least two (2) of the following signs are present in at least one ear: Full or
bulging or perforated tympanic membrane, which may be erythematous (note - since
hyperemia may be present in a febrile or crying child, a red tympanic membrane alone
is insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks
(opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasic
pneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membrane
and edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated by
acoustic reflect tympanometry (ear check) showing values of 3, 4 or 5.
- Generally in good health based on medical history, vital signs, physical exam, and
historical laboratory results.
- Subject must be a suitable candidate for oral antibiotic therapy.
Exclusion Criteria:
- Previous enrollment in this study.
- Enrollment in any other investigational study using unapproved products or unapproved
doses; in the previous four weeks prior to study start.
- Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, other
macrolide and azalide antibiotics, and/or sensitivity to multiple allergens.
- Presence of tympanostorny tubes or otitis externa at Evaluation 1.
- Systemic treatment with any anti-infective agent within 14 days 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 perforation of the tympanic membrane > 24 hours.
- Evidence of a physiologic, anatomic, or immunologic defect, which would interfere
with resolution of this episode of acute otitis media.
- Immunocompromised subject (e. g., neutropenic subjects).
- Presence of a disease, complicating factor (e. g., mastoiditis), or structural
abnormality that would preclude evaluation of the subject's therapeutic response.
- Any expectation that treatment with probenecid will be expected during the study drug
administration period.
- Known significant renal or hepatic impairment.
Locations and Contacts
Columbiana, Alabama 35051, United States
Montgomery, Alabama 36116, United States
Ozark, Alabama 36360, United States
Fresno, California 93710, United States
Fresno, California 93720, United States
Marietta, Georgia 30062, United States
Stone Mountain, Georgia 30087, United States
Dubuque, Iowa 52002, United States
Bardstown, Kentucky 40004, United States
Louisville, Kentucky 40207, United States
Owensboro, Kentucky 42303, United States
Cadillac, Michigan 49601, United States
Kalamazoo, Michigan 49008, United States
Portage, Michigan 49024, United States
Richland, Michigan 49083, United States
Omaha, Nebraska 68178, United States
Columbus, Ohio 43205, United States
Huber Heights, Ohio 45424, United States
Pittsburgh, Pennsylvania 15241, United States
Reading, Pennsylvania 19606, United States
Sellersville, Pennsylvania 18960, United States
Charleston, South Carolina 29425, United States
Kingsport, Tennessee 37664, United States
Lake Jackson, Texas 77566, United States
Salt Lake City, Utah 84109, United States
Salt Lake City, Utah 84121, United States
West Jordan, Utah 84008, United States
West Jordan, Utah 84084, United States
Vienna, Virginia 22180, United States
Monroe, Wisconsin 53566, United States
Additional Information
Starting date: November 2003
Last updated: March 22, 2008
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