A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
1 other identifier
interventional
357
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 22, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedMarch 27, 2008
March 1, 2008
2 months
March 22, 2008
March 22, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical cure rate at Evaluation 2
9 days
Secondary Outcomes (1)
Sustained clinical cure rate at Evaluation 4
25 days
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
oral suspension, 7 mg/kg every 12 hours for 5 days
oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (30)
Unknown Facility
Columbiana, Alabama, 35051, United States
Unknown Facility
Montgomery, Alabama, 36116, United States
Unknown Facility
Ozark, Alabama, 36360, United States
Unknown Facility
Fresno, California, 93710, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
Marietta, Georgia, 30062, United States
Unknown Facility
Stone Mountain, Georgia, 30087, United States
Unknown Facility
Dubuque, Iowa, 52002, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Louisville, Kentucky, 40207, United States
Unknown Facility
Owensboro, Kentucky, 42303, United States
Unknown Facility
Cadillac, Michigan, 49601, United States
Unknown Facility
Kalamazoo, Michigan, 49008, United States
Unknown Facility
Portage, Michigan, 49024, United States
Unknown Facility
Richland, Michigan, 49083, United States
Unknown Facility
Omaha, Nebraska, 68178, United States
Unknown Facility
Columbus, Ohio, 43205, United States
Unknown Facility
Huber Heights, Ohio, 45424, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Unknown Facility
Reading, Pennsylvania, 19606, United States
Unknown Facility
Sellersville, Pennsylvania, 18960, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Kingsport, Tennessee, 37664, United States
Unknown Facility
Lake Jackson, Texas, 77566, United States
Unknown Facility
Salt Lake City, Utah, 84109, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
West Jordan, Utah, 84008, United States
Unknown Facility
West Jordan, Utah, 84084, United States
Unknown Facility
Vienna, Virginia, 22180, United States
Unknown Facility
Monroe, Wisconsin, 53566, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 22, 2008
First Posted
March 27, 2008
Study Start
November 1, 2003
Primary Completion
January 1, 2004
Last Updated
March 27, 2008
Record last verified: 2008-03