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Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00768534
First Posted: October 8, 2008
Last Update Posted: October 6, 2016
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media

Condition
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)
  Eligibility

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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00768534


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00768534     History of Changes
Other Study ID Numbers: 0887X1-4454
B1841014 ( Other Identifier: Alias Study Number )
First Submitted: October 7, 2008
First Posted: October 8, 2008
Last Update Posted: October 6, 2016
Last Verified: October 2016

Keywords provided by Pfizer:
Acute Otitis Media
Serotype distribution

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases