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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Cefdinir; Cephalosporins

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