A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

March 21, 2008 updated by: Abbott
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
      • Montgomery, Alabama, United States, 36116
      • Ozark, Alabama, United States, 36360
    • Arizona
      • Mesa, Arizona, United States, 85201
      • Scottsdale, Arizona, United States, 85251
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
    • California
      • Clovis, California, United States, 93612
      • Fresno, California, United States, 93270
    • Colorado
      • Longmont, Colorado, United States, 80501
    • Connecticut
      • Fairfield, Connecticut, United States, 06430
    • Georgia
      • Marietta, Georgia, United States, 30062
      • Stone Mountain, Georgia, United States, 30087
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
      • Louisville, Kentucky, United States, 40207
      • Owensboro, Kentucky, United States, 42301
    • Louisiana
      • Ruston, Louisiana, United States, 71270
      • Shreveport, Louisiana, United States, 71105
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
      • Richland, Michigan, United States, 49083
    • Nebraska
      • Omaha, Nebraska, United States, 68178
    • Nevada
      • Las Vegas, Nevada, United States, 89104
    • Ohio
      • Columbus, Ohio, United States, 43205
    • Oregon
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
      • Sellersville, Pennsylvania, United States, 18960
    • South Carolina
      • Charleston, South Carolina, United States, 29403
    • Texas
      • Austin, Texas, United States, 78758
      • Lake Jackson, Texas, United States, 77566
    • Utah
      • Salt Lake City, Utah, United States, 84121
      • Salt Lake City, Utah, United States, 84109
      • West Jordan, Utah, United States, 84084
    • Virginia
      • Vienna, Virginia, United States, 22180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: amoxicillin
oral suspension (45 mg/kg/day, q l2 hours) for 10 days
Active Comparator: 1
Drug: cefdinir (Omnicef)
oral suspension (7 mg/kg, ql2hr) for 5 days
Other Names:
  • ABT-198
  • Omnicef
  • cefdinir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Cure Rate
Time Frame: 9 days
9 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Sustained Clinical Cure Rate
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

March 27, 2008

Last Update Submitted That Met QC Criteria

March 21, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-541

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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