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Trial record 47 of 433 for:    OTITIS

Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00768534
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : October 6, 2016
Information provided by (Responsible Party):

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

Condition or disease
Otitis Media

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Study Type : Observational
Actual Enrollment : 2138 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates
Study Start Date : October 2008
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00768534

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

Additional Information:
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Responsible Party: Pfizer Identifier: NCT00768534     History of Changes
Other Study ID Numbers: 0887X1-4454
B1841014 ( Other Identifier: Alias Study Number )
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Keywords provided by Pfizer:
Acute Otitis Media
Serotype distribution
Additional relevant MeSH terms:
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Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases