A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00645112
First received: March 22, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin 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 at Evaluation 2 [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained clinical cure rate at Evaluation 4 [ Time Frame: 25 days ] [ Designated as safety issue: No ]

Enrollment: 357
Study Start Date: November 2003
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: cefdinir (Omnicef)
oral suspension, 7 mg/kg every 12 hours for 5 days
Other Names:
  • ABT-198
  • Omnicef
  • cefdinir
Active Comparator: 2 Drug: azithromycin
oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.
Other Name: azithromycin

  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 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.
  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: NCT00645112

  Show 30 Study Locations
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Angela M Nilius, Abbott
ClinicalTrials.gov Identifier: NCT00645112     History of Changes
Other Study ID Numbers: M03-630
Study First Received: March 22, 2008
Last Updated: March 22, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Cefdinir
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014