A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
1 other identifier
interventional
425
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedMarch 27, 2008
March 1, 2008
2 months
March 21, 2008
March 21, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Cure Rate
9 days
Secondary Outcomes (1)
Sustained Clinical Cure Rate
28 days
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
oral suspension (7 mg/kg, ql2hr) for 5 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (32)
Unknown Facility
Birmingham, Alabama, 35211, United States
Unknown Facility
Montgomery, Alabama, 36116, United States
Unknown Facility
Ozark, Alabama, 36360, United States
Unknown Facility
Mesa, Arizona, 85201, United States
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
Little Rock, Arkansas, 72211, United States
Unknown Facility
Clovis, California, 93612, United States
Unknown Facility
Fresno, California, 93270, United States
Unknown Facility
Longmont, Colorado, 80501, United States
Unknown Facility
Fairfield, Connecticut, 06430, United States
Unknown Facility
Marietta, Georgia, 30062, United States
Unknown Facility
Stone Mountain, Georgia, 30087, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Louisville, Kentucky, 40207, United States
Unknown Facility
Owensboro, Kentucky, 42301, United States
Unknown Facility
Ruston, Louisiana, 71270, United States
Unknown Facility
Shreveport, Louisiana, 71105, United States
Unknown Facility
Kalamazoo, Michigan, 49008, United States
Unknown Facility
Richland, Michigan, 49083, United States
Unknown Facility
Omaha, Nebraska, 68178, United States
Unknown Facility
Las Vegas, Nevada, 89104, United States
Unknown Facility
Columbus, Ohio, 43205, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Unknown Facility
Sellersville, Pennsylvania, 18960, United States
Unknown Facility
Charleston, South Carolina, 29403, United States
Unknown Facility
Austin, Texas, 78758, 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, 84084, United States
Unknown Facility
Vienna, Virginia, 22180, 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
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 21, 2008
First Posted
March 27, 2008
Study Start
February 1, 2003
Primary Completion
April 1, 2003
Last Updated
March 27, 2008
Record last verified: 2008-03