Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

Study Identifier
M01-352
CT.gov Identifier
NCT00645203
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Bacterial Infection
    • Study Drug
  • cefdinir
    • Phase
    CSR.ORG
    Sex
    Female & Male
    Age
    6 Months - 4 Years
    Inclusion and Exclusion 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

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Scottsdale, Arizona, United States, 85258
    Status
    Not applicable
    Location
    Clovis, California, United States, 93611
    Status
    Not applicable
    Location
    Dinuba, California, United States, 93618
    Status
    Not applicable
    Location
    Folsom, California, United States, 95630
    Status
    Not applicable
    Location
    Denver, Colorado, United States, 80218
    Status
    Not applicable
    Location
    Brooklyn, New York, United States, 11203
    Status
    Not applicable
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