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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

Page last updated: June 20, 2008

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