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A Study Evaluating Pathogens and Immunity to Acute Otitis Media and Nasopharyngeal Colonization in Healthy Children.
The purpose of this study is to Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
A prospective evaluation of bacterial pathogens Streptococcus. pneumoniae, Haemophilus influenzae, Moraxella. catarrhalis and Staphylococcus aureus and their antibiotic susceptibility when colonizing the nasopharynx and/or causing acute otitis media in the years 2015-2025. The goal will be to recruit children into a prospective group beginning at 6 months of age and followed to 36 months of age in suburban Rochester, New York. Nasopharyngeal and nasal wash samples will be obtained at each well child visit and at acute otitis media (AOM) episodes. Middle ear fluid will be obtained from every child with an acute otitis media episode who undergoes a tympanocentesis procedure. All of the nasopharyngeal and middle ear fluid samples collected will be tested by standard microbiologic techniques to identify the presence of 4 potential otopathogens (S. pneumoniae, H. influenzae, M. catarrhalis and S. aureus). All S. pneumoniae will undergo serotyping and antibiotic susceptibility testing. All samples that are culture negative will be evaluated with a multi-locus PCR test to examine for presence of potential otopathogens.
Age
0 - 3 years
Sex
ALL
Healthy Volunteers
Yes
Rochester General Hospital
Rochester, New York, United States
Start Date
October 1, 2015
Primary Completion Date
December 1, 2025
Completion Date
December 1, 2025
Last Updated
November 22, 2023
1,320
ACTUAL participants
procedures
OTHER
Lead Sponsor
Rochester General Hospital
Data Source & Attribution
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