Acute Otitis Media
Conditions
Brief 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.
Interventions
DRUGcefdinir
cefdinir oral suspension, 25 mg/kg once daily for 10 days
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacteriological Response | 30 days |
| Clinical response | 30 days |
| Change in the otoscopic findings | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Physical exam; Vital signs; Use of concomitant medications | 59 days |
| Adverse events assessment | 45 days with follow-up to a satisfactory conclusion |
| Laboratory evaluations | 30 days |
Countries
Chile, Costa Rica, Dominican Republic, Guatemala, Israel, Panama, United States
Outcome results
None listed