Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

Rochester General Hospital1,320 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,320

Conditions

Nasopharyngeal Colonization and Acute Otitis Media

Interventions

proceduresOTHER

Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis (if acute otitis media occurs), venipuncture

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 36 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Healthy Children: * Male or female age greater than/equal to 6 months or less than/equal to 36 months old. * Parent/guardian willing to bring to all study visits Exclusion Criteria: * Any major illness/condition that in investigator opinion would put subject at risk during study. * Otorrhea or tympanostomy tubes present in either ear @ time of enrollment. * Direct descendant of study site personnel. * Subjects \< 6 months old or \>36 months old at the time of enrollment

Locations (1)

Rochester General Hospital

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 10 years

Secondary Outcomes

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.

Time frame: 10 years

Data from ClinicalTrials.gov

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