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
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00768534
First received: October 7, 2008
Last updated: October 1, 2015
Last verified: October 2015

October 7, 2008
October 1, 2015
October 2008
December 2015   (final data collection date for primary outcome measure)
serotype distribution [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00768534 on ClinicalTrials.gov Archive Site
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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
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:
Middle ear fluid and anasopharyngeal swab
Non-Probability Sample
community sample
Otitis Media
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
December 2015
December 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
Both
2 Months to 5 Years   (Child)
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Germany
 
NCT00768534
0887X1-4454, B1841014
No
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Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP