Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
AOM
A Study Evaluating Pathogens and Immunity to Acute Otitis Media and Nasopharyngeal Colonization in Healthy Children.
1 other identifier
observational
1,320
1 country
1
Brief Summary
The purpose of this study is to Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 28, 2015
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedNovember 22, 2023
November 1, 2023
10.2 years
October 28, 2015
November 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
10 years
Secondary Outcomes (1)
The distribution of potential otopathogens colonizing the nasopharynx.
10 years
Study Arms (1)
Healthy children
6-36 months of age who will have the following study procedures: Venipuncture, Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis
Interventions
Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis (if acute otitis media occurs), venipuncture
Eligibility Criteria
Healthy 6-36 month old children or Acute Otitis Media diagnosed children \>/= 6mo but \</= 36 months
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rochester General Hospital
Rochester, New York, 14621, United States
Biospecimen
middle ear fluid, nasal swabs, nasal wash, and blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael E Pichichero, MD
Rochester General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Director, Rochester General Hospital Research Institute
Study Record Dates
First Submitted
October 28, 2015
First Posted
October 29, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
November 22, 2023
Record last verified: 2023-11