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

Abbott

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Otitis Media

Treatments: Drug: cefdinir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645203

M01-352

Details and patient eligibility

About

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.

Enrollment: 447 patients

Sex: All

Ages: 6 months to 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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447 participants in 1 patient group

1

Other group

Treatment:

Drug: cefdinir