An observational study in Nasopharyngeal Colonization and Acute Otitis Media, sponsored by Rochester General Hospital. Active, not recruiting at 1 site in United States. Open to participants aged 6 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Rochester General Hospital · Observational
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.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
This study's enrollment of 1,320 is above the median of 150 across 57 observational studies indexed under Otitis Media.
Browse Otitis Media studies →Rochester General Hospital is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy 6-36 month old children or Acute Otitis Media diagnosed children >/= 6mo but \</= 36 months
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy Children:
Exclusion Criteria:
6-36 months of age who will have the following study procedures: Venipuncture, Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis
Other: procedures
Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis (if acute otitis media occurs), venipuncture
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
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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rochester General Hospital