Otitis Media Clinical Trial
Official title:
Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates
Verified date | October 2016 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Paul-Ehrlich-Institut |
Study type | Observational |
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media
Status | Completed |
Enrollment | 2138 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Months to 5 Years |
Eligibility |
Inclusion Criteria: Main inclusion criteria: - Children >= 2 months and =< 5 years - Spontaneous draining AOM =< 2 days Main Exclusion Criteria: exclusion criteria: - Previous operation of the ear - Chronic otitis media or tube placement with drainage >= 3 days - Chronic disease/immune deficiency |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Dr. Andreas Busse | Tegernsee | Bavarian |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serotype distribution | 30 days | No |
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