- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02591563
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
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
-
-
New York
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Rochester, New York, United States, 14621
- Rochester General Hospital
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-
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
|
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
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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