Status:
COMPLETED
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
Lead Sponsor:
Abbott
Conditions:
Acute Otitis Media
Eligibility:
All Genders
6-4 years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT00645203
Start Date
July 1 2002
Last Update
March 27 2008
Active Locations (22)
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1
Scottsdale, Arizona, United States, 85258
2
Clovis, California, United States, 93611
3
Dinuba, California, United States, 93618
4
Folsom, California, United States, 95630