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NCT00768534 Clinical Trial

Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

Otitis Media Clinical Trial

Official title:
Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00768534
Other study ID # 0887X1-4454
Secondary ID B1841014
Status Completed
Phase N/A
First received October 7, 2008
Last updated October 5, 2016
Start date October 2008
Est. completion date October 2015

Study information
Verified date October 2016
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Observational

Clinical Trial Summary

Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media

Recruitment information / eligibility
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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Dr. Andreas Busse Tegernsee Bavarian

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary serotype distribution 30 days No
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