Acute Otitis Media Clinical Trial
Official title:
An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media
NCT number | NCT00645203 |
Other study ID # | M01-352 |
Secondary ID | |
Status | Completed |
Phase | Phase 2/Phase 3 |
First received | March 20, 2008 |
Last updated | March 20, 2008 |
Start date | July 2002 |
Verified date | March 2008 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 447 |
Est. completion date | |
Est. primary completion date | April 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 4 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott |
United States, Chile, Costa Rica, Dominican Republic, Guatemala, Israel, Panama,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bacteriological Response | 30 days | No | |
Primary | Clinical response | 30 days | No | |
Primary | Change in the otoscopic findings | 30 days | No | |
Secondary | Physical exam; Vital signs; Use of concomitant medications | 59 days | Yes | |
Secondary | Adverse events assessment | 45 days with follow-up to a satisfactory conclusion | Yes | |
Secondary | Laboratory evaluations | 30 days | Yes |
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