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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00644943
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
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Brief 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.

Condition or disease Intervention/treatment Phase
Acute Otitis Media Drug: cefdinir (Omnicef) Drug: amoxicillin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 425 participants
Allocation: Randomized
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
Study Start Date : February 2003
Actual Primary Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Active Comparator: 1 Drug: cefdinir (Omnicef)
oral suspension (7 mg/kg, ql2hr) for 5 days
Other Names:
  • ABT-198
  • Omnicef
  • cefdinir

Active Comparator: 2 Drug: amoxicillin
oral suspension (45 mg/kg/day, q l2 hours) for 10 days

Primary Outcome Measures :
  1. Clinical Cure Rate [ Time Frame: 9 days ]

Secondary Outcome Measures :
  1. Sustained Clinical Cure Rate [ Time Frame: 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00644943

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Sponsors and Collaborators

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Responsible Party: Angela M Nilius, Ph.D., Abbott Identifier: NCT00644943     History of Changes
Other Study ID Numbers: M02-541
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action