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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00644943
First received: March 21, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention Phase
Acute Otitis Media
Drug: cefdinir (Omnicef)
Drug: amoxicillin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Clinical Cure Rate [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained Clinical Cure Rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 425
Study Start Date: February 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: amoxicillin

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644943

  Show 32 Study Locations
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Angela M Nilius, Ph.D., Abbott
ClinicalTrials.gov Identifier: NCT00644943     History of Changes
Other Study ID Numbers: M02-541
Study First Received: March 21, 2008
Last Updated: March 21, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acid
Cefdinir
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014