Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
- Registration Number
- NCT00645203
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 447
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 cefdinir -
- Primary Outcome Measures
Name Time Method Bacteriological Response 30 days Clinical response 30 days Change in the otoscopic findings 30 days
- Secondary Outcome Measures
Name Time Method Adverse events assessment 45 days with follow-up to a satisfactory conclusion Physical exam; Vital signs; Use of concomitant medications 59 days Laboratory evaluations 30 days