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Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: October 7, 2008
Last updated: October 5, 2016
Last verified: October 2016
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media

Otitis Media

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • serotype distribution [ Time Frame: 30 days ]

Biospecimen Retention:   Samples Without DNA
Middle ear fluid and anasopharyngeal swab

Enrollment: 2138
Study Start Date: October 2008
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   2 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00768534

Dr. Andreas Busse
Tegernsee, Bavarian, Germany, 83684
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00768534     History of Changes
Other Study ID Numbers: 0887X1-4454
B1841014 ( Other Identifier: Alias Study Number )
Study First Received: October 7, 2008
Last Updated: October 5, 2016

Keywords provided by Pfizer:
Acute Otitis Media
Serotype distribution

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases processed this record on September 21, 2017