Otitis Media
Conditions
Brief summary
Assess tolerability of different dosing formulations (adult versus pediatric).
Interventions
DRUGZmax
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
3 Months to 48 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-vomiting (in minutes) will be measured for all vomiting episodes that occur within the 60-minute observation period post-dosing on Day 1. | — |
| Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population. | — |
| Frequencies of occurrence, by day, of treatment-related vomiting. | — |
| Investigator and Sponsor assessment of clinical response. | — |
Countries
Argentina, Chile, Costa Rica, Dominican Republic, Guatemala, Panama, United States
Outcome results
None listed