ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00768534
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease
Otitis Media

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
U.S. FDA Resources




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

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, Learn About Clinical Studies.


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

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

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 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:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases