Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media

Pfizer

Status and phase: Completed; Phase 3

Conditions: Otitis Media

Treatments: Drug: Zmax

Study type: Interventional

Funder types: Industry

Identifiers

NCT00360100

A0661170

Details and patient eligibility

About

Assess tolerability of different dosing formulations (adult versus pediatric).

Enrollment: 120 patients

Sex: All

Ages: 3 to 48 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have clinical signs/symptoms of AOM in at least 1 ear

Exclusion criteria

• Known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor
• Previously diagnosed disease(s) of immune function
• Treatment with any systemic (intravenous, intramuscular, oral) antibiotic for any indication within 7 days prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind