Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

This study is currently recruiting participants.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00768534
First received: October 7, 2008
Last updated: April 11, 2014
Last verified: April 2014

October 7, 2008
April 11, 2014
September 2008
April 2014   (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

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
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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
1000
April 2014
April 2014   (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
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Germany
 
NCT00768534
0887X1-4454
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2014

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