Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00768534
First received: October 7, 2008
Last updated: September 10, 2014
Last verified: September 2014
  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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Middle ear fluid and anasopharyngeal swab


Estimated Enrollment: 2000
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
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 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:
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: September 10, 2014
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 October 23, 2014