Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

Completed

• Conditions: Otitis Media

• Registration Number: NCT00768534
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2138

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serotype distribution	30 days

Trial Locations

Locations (1)

Dr. Andreas Busse; 🇩🇪 Tegernsee, Bavarian, Germany