Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: October 7, 2008
Last updated: October 1, 2015
Last verified: October 2015
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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 2500
Study Start Date: October 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00768534

Contact: Pfizer Call Center 1-800-718-1021

Dr. Andreas Busse Recruiting
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 
Study First Received: October 7, 2008
Last Updated: October 1, 2015
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Pfizer:
Acute Otitis Media
Serotype distribution

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases processed this record on May 22, 2016