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

NCT ID: NCT02591563

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

Detailed Description

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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.

Conditions

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Nasopharyngeal Colonization and Acute Otitis Media

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy children

6-36 months of age who will have the following study procedures: Venipuncture, Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis

procedures

Intervention Type OTHER

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

Interventions

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procedures

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rochester General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Pichichero

MD, Director, Rochester General Hospital Research Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael E Pichichero, MD

Role: PRINCIPAL_INVESTIGATOR

Rochester General Hospital

Locations

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Rochester General Hospital

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CIC 1141 B-09-1

Identifier Type: -

Identifier Source: org_study_id