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

Completed · Phase 3

Conditions studied: Otitis Media

In brief

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

Key facts

Study ID

NCT00360100

Run by

Pfizer

People needed

120

Starts

2006-08-01

Expected to finish

2006-12-01

Last updated by the study team

2011-05-17

Who can join

Age: 0 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Bardstown, Kentucky, United States
• Pfizer Investigational Site — Springfield, Kentucky, United States
• Pfizer Investigational Site — Córdoba, Córdoba Province, Argentina
• Pfizer Investigational Site — Santiago, RM, Chile
• Pfizer Investigational Site — Independencia, Santiago Metropolitan, Chile
• Pfizer Investigational Site — Providencia, Santiago Metropolitan, Chile
• Pfizer Investigational Site — San José, Costa Rica
• Pfizer Investigational Site — Santo Domingo, DN, Dominican Republic
• Pfizer Investigational Site — Guatemala City, Guatemala
• Pfizer Investigational Site — Panama City, Panama

Full record on ClinicalTrials.gov

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