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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
October 7, 2008
October 8, 2008
October 6, 2016
October 2008
October 2015   (Final data collection date for primary outcome measure)
serotype distribution [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT00768534 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Middle ear fluid and anasopharyngeal swab
Non-Probability Sample
community sample
Otitis Media
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2138
October 2015
October 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Months to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00768534
0887X1-4454
B1841014 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2016