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Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00768534
First received: October 7, 2008
Last updated: June 13, 2013
Last verified: June 2013
History of Changes
  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:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • serotype distribution [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Middle ear fluid and anasopharyngeal swab


Estimated Enrollment: 1000
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Months to 5 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768534

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Germany
Pfizer Investigational Site Recruiting
Tegernsee, Bavarian, Germany, 83684
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00768534     History of Changes
Other Study ID Numbers: 0887X1-4454
Study First Received: October 7, 2008
Last Updated: June 13, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Pfizer:
Acute Otitis Media
Serotype distribution

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

ClinicalTrials.gov processed this record on June 18, 2013