A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

Last updated: March 22, 2008
Sponsor: Abbott
Overall Status: Completed

Phase

4

Condition

Ear Infections

Otitis Media

Ear Infections (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00645112
M03-630
  • Ages 6-6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis, documented by medical history and physical examination, is AOM I 1week.

  • Clinical symptoms include >=1 of the following: Otalgia (earache or pain), this may beexpressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may bebased on reports from parents or legally authorized representatives; Discharge fromthe 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 orbulging or perforated tympanic membrane, which may be erythematous (note - sincehyperemia may be present in a febrile or crying child, a red tympanic membrane aloneis insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks (opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasicpneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membraneand edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated byacoustic reflect tympanometry (ear check) showing values of 3, 4 or 5.

  • Generally in good health based on medical history, vital signs, physical exam, andhistorical laboratory results.

  • Subject must be a suitable candidate for oral antibiotic therapy.

Exclusion

Exclusion Criteria:

  • Previous enrollment in this study.

  • Enrollment in any other investigational study using unapproved products or unapproveddoses; in the previous four weeks prior to study start.

  • Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, othermacrolide 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 1or during the study.

  • Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin Gbenzathine) 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 withresolution of this episode of acute otitis media.

  • Immunocompromised subject (e.g., neutropenic subjects).

  • Presence of a disease, complicating factor (e.g., mastoiditis), or structuralabnormality that would preclude evaluation of the subject's therapeutic response.

  • Any expectation that treatment with probenecid will be expected during the study drugadministration period.

  • Known significant renal or hepatic impairment.

Study Design

Total Participants: 357
Study Start date:
November 01, 2003
Estimated Completion Date:

Connect with a study center

  • Columbiana, Alabama 35051
    United States

    Site Not Available

  • Montgomery, Alabama 36116
    United States

    Site Not Available

  • Ozark, Alabama 36360
    United States

    Site Not Available

  • Fresno, California 93710
    United States

    Site Not Available

  • Marietta, Georgia 30062
    United States

    Site Not Available

  • Stone Mountain, Georgia 30087
    United States

    Site Not Available

  • Dubuque, Iowa 52002
    United States

    Site Not Available

  • Bardstown, Kentucky 40004
    United States

    Site Not Available

  • Louisville, Kentucky 40207
    United States

    Site Not Available

  • Owensboro, Kentucky 42303
    United States

    Site Not Available

  • Cadillac, Michigan 49601
    United States

    Site Not Available

  • Kalamazoo, Michigan 49008
    United States

    Site Not Available

  • Portage, Michigan 49024
    United States

    Site Not Available

  • Richland, Michigan 49083
    United States

    Site Not Available

  • Omaha, Nebraska 68178
    United States

    Site Not Available

  • Columbus, Ohio 43205
    United States

    Site Not Available

  • Huber Heights, Ohio 45424
    United States

    Site Not Available

  • Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Reading, Pennsylvania 19606
    United States

    Site Not Available

  • Sellersville, Pennsylvania 18960
    United States

    Site Not Available

  • Charleston, South Carolina 29425
    United States

    Site Not Available

  • Kingsport, Tennessee 37664
    United States

    Site Not Available

  • Lake Jackson, Texas 77566
    United States

    Site Not Available

  • Salt Lake City, Utah 84109
    United States

    Site Not Available

  • West Jordan, Utah 84008
    United States

    Site Not Available

  • Vienna, Virginia 22180
    United States

    Site Not Available

  • Monroe, Wisconsin 53566
    United States

    Site Not Available

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