Nasopharyngeal Colonization and Acute Otitis MediaAOMNCT02591563
Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
An observational study of Nasopharyngeal Colonization and Acute Otitis Media, run by Rochester General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Colonization and Acute Otitis Media
- What is being tested?
- procedures
- How many people
- 1,320 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy 6-36 month old children or Acute Otitis Media diagnosed children >/= 6mo but </= 36 months
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester General Hospital
Rochester, New York, 14621
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- procedures
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proceduresOther
Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis (if acute otitis media occurs), venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Healthy children | 6-36 months of age who will have the following study procedures: Venipuncture, Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis Receives: Other: procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Colonization and Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rochester General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Pichichero, Rochester General Hospital
- Investigators
- Michael E Pichichero, MD, Principal investigator, Rochester General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591563
- Sponsor's protocol ID
- CIC 1141 B-09-1
- Acronym
- AOM
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2015
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes