Expired Study
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Denver, Colorado 80218


Purpose:

To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.


Criteria:

Inclusion Criteria: - Male and female children between 6 months and 4 years of age - 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: - Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications - 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


NCT ID:

NCT00645203


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Denver, Colorado 80218
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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