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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy children | 6-36 months of age who will have the following study procedures: Venipuncture, Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| procedures | Other | Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis (if acute otitis media occurs), venipuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| The distribution of bacteria causing acute otitis media. | In this study, we are exploring the three main bacteria (Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis) isolated from middle ear fluid samples (obtained by tympanocentesis) during acute otitis media episode in children ages 6-36 months. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| The distribution of potential otopathogens colonizing the nasopharynx. | In this study we are exploring the three main bacteria (Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis) isolated from nasopharynx of children during their routine healthy visits at 6-36 months of age during an AOM episode. | 10 years |
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Inclusion Criteria:
Healthy Children:
Exclusion Criteria:
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Healthy 6-36 month old children or Acute Otitis Media diagnosed children >/= 6mo but \
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| Name | Affiliation | Role |
|---|---|---|
| Michael E Pichichero, MD | Rochester General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester General Hospital | Rochester | New York | 14621 | United States |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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middle ear fluid, nasal swabs, nasal wash, and blood