Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
NCT ID: NCT00645203
Last Updated: 2008-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
447 participants
INTERVENTIONAL
2002-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
cefdinir
cefdinir oral suspension, 25 mg/kg once daily for 10 days
Interventions
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cefdinir
cefdinir oral suspension, 25 mg/kg once daily for 10 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight does not exceed 40 kg
* Clinical diagnosis is acute otitis media
* Have evidence of middle ear fluid
* At risk for persistent or recurrent otitis media
* Generally in good health
Exclusion Criteria
* Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear
* Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study
* Concomitant infection, that requires additional antimicrobial therapy
* Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response
6 Months
4 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Locations
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Scottsdale, Arizona, United States
Clovis, California, United States
Dinuba, California, United States
Folsom, California, United States
Denver, Colorado, United States
Brooklyn, New York, United States
Rochester, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Erie, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Providencia, Santiago Metropolitan, Chile
Puente Alto, Santiago, , Chile
Uruca, Provincia de San José, Costa Rica
San José, , Costa Rica
Santo Domingo, , Dominican Republic
Guatemala City, , Guatemala
Guatemala City, , Guatemala
Beersheba, , Israel
Panama City, , Panama
Countries
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Other Identifiers
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M01-352
Identifier Type: -
Identifier Source: org_study_id