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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

Page last updated: August 23, 2015

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