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

November 21, 2023 updated by: Michael Pichichero, Rochester General Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14621
        • Rochester General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy 6-36 month old children or Acute Otitis Media diagnosed children >/= 6mo but </= 36 months

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy children
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The distribution of bacteria causing acute otitis media.
Time Frame: 10 years
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The distribution of potential otopathogens colonizing the nasopharynx.
Time Frame: 10 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rochester General Hospital

Investigators

  • Principal Investigator: Michael E Pichichero, MD, Rochester General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimated)

October 29, 2015

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIC 1141 B-09-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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